Motivational Interviewing with Computer Assistance as an intervention to empower women to make contraceptive choices while incarcerated: study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: Unplanned pregnancies (defined as pregnancies that are either mistimed or unwanted) and sexually transmitted infections (STIs) are important and costly public health problems in the United States resulting from unprotected sexual intercourse. Women with a history of incarceration are at increased risk for these problems given the high rates of substance abuse and commercial sex work in this population.[1] Project CARE (Contraceptive Awareness and Reproductive Education) is designed to evaluate an innovative intervention, Motivational Interviewing with Computer Assistance (MICA), aimed at enhancing contraceptive initiation and maintenance among incarcerated women who do not want a pregnancy within the next year and who are anticipated to be released back to the community. This study aims to: (1) increase the initiation of highly effective contraceptives while incarcerated; (2) increase the continuation of highly effective contraceptive use at 3, 6, 9, and 12 months after release; and (3) decrease unsafe sexual activity. METHODS: This prospective study will recruit 400 women from the Rhode Island Department of Corrections (RI DOC) women's jail at risk for an unplanned pregnancy (i.e. sexually active with men and not planning/wanting to become pregnant in the next year). They will be randomized to two interventions: a control group who receive two educational videos (on contraception, STIs and pre-conception counseling) or a treatment group who receive two sessions of personalized MICA. MICA is based on the principles of the Transtheoretical Model (TTM)[2, 3] and on Motivational Interviewing (MI),[4] an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. Women will be followed at 3, 6, 9 and 12 months post release and assessed for STIs, pregnancy and reported condom use. DISCUSSION: Results from this study are expected to enhance our understanding of the efficacy of MICA to enhance contraceptive initiation and maintenance and reduce sexual risk-taking behaviors among incarcerated women who have reentered the community. Trial Registration: NCT01132950.     

Unmet Need for Family Planning,Contraceptive Failure,and Unintended Pregnancy among HIV-Infected and HIV-Uninfected Women in Zimbabwe

Background

Prevention of unintended pregnancies among women living with HIV infection is a strategy recommended by the World Health Organization for prevention of mother-to-child transmission of HIV (PMTCT). We assessed pregnancy intentions and contraceptive use among HIV-positive and HIV-negative women with a recent pregnancy in Zimbabwe.

Methods

We analyzed baseline data from the evaluation of Zimbabwe’s Accelerated National PMTCT Program. Eligible women were randomly sampled from the catchment areas of 157 health facilities offering PMTCT services in five provinces. Eligible women were ≥16 years old and mothers of infants (alive or deceased) born 9 to 18 months prior to the interview. Participants were interviewed about their HIV status, intendedness of the birth, and contraceptive use.

Results

Of 8,797 women, the mean age was 26.7 years, 92.8% were married or had a regular sexual partner, and they had an average of 2.7 lifetime births. Overall, 3,090 (35.1%) reported that their births were unintended; of these women, 1,477 (47.8%) and 1,613 (52.2%) were and were not using a contraceptive method prior to learning that they were pregnant, respectively. Twelve percent of women reported that they were HIV-positive at the time of the survey; women who reported that they were HIV-infected were significantly more likely to report that their pregnancy was unintended compared to women who reported that they were HIV-uninfected (44.9% vs. 33.8%, p<0.01). After adjustment for covariates, among women with unintended births, there was no association between self-reported HIV status and lack of contraception use prior to pregnancy.

Conclusions

Unmet need for family planning and contraceptive failure contribute to unintended pregnancies among women in Zimbabwe. Both HIV-infected and HIV-uninfected women reported unintended pregnancies despite intending to avoid or delay pregnancy, highlighting the need for effective contraceptive methods that align with pregnancy intentions.     

Qualitative Inquiry into Premarital Sexual Behaviours and Contraceptive Use among Multiethnic Young Women: Implications for Education and Future Research

Background

This study was a qualitative investigation into sexual attitudes and behaviours, and contraceptive use among Malaysian youth, based on constructs from the health belief model, theory of reasoned action, and problem behaviour theory.

Methods

A total of 34 focus group discussions with 185 participants were conducted among the Malay (35%), Chinese (34%), and Indian (31%) young females between November, 2010 and April, 2011. The participants were secondary school students and university undergraduates from Selangor and the Federal Territory of Kuala Lumpur.

Results

The study found a lack of knowledge about sexual issues and contraception among the participants. Many engaged in unprotected sexual intercourse and relied on periodic abstinence, natural methods, and traditional folk pregnancy preventive practices. The findings also revealed numerous categories of factors influencing sexual attitudes and behaviours: ethnic group and religion, level of religiosity, peer pressure and norms, and parental monitoring. With regard to condom use, factors such as embarrassment about condom acquisition, low perceived susceptibility to sexually transmitted infections (STIs), and perceived efficacy of traditional and folk methods of contraception, were uncovered from the discussions.

Conclusion

This study underscores the importance of development of culturally specific interventions that address the identified promoting factors of premarital sex. Behavioral interventions to promote condom use should increase awareness about condom effectiveness against not only unwanted pregnancies but also STIs.     

High incidence of unplanned pregnancy after antiretroviral therapy initiation: findings from a prospective cohort study in South Africa

Background

Increased fertility rates in HIV-infected women receiving antiretroviral therapy (ART) have been attributed to improved immunological function; it is unknown to what extent the rise in pregnancy rates is due to unintended pregnancies.

Methods

Non-pregnant women ages 18–35 from four public-sector ART clinics in Johannesburg, South Africa, were enrolled into a prospective cohort and followed from August 2009–March 2011. Fertility intentions, contraception and pregnancy status were measured longitudinally at participants'' routine ART clinic visits.

Findings

Of the 850 women enrolled, 822 (97%) had at least one follow-up visit and contributed 745.2 person-years (PY) at-risk for incident pregnancy. Overall, 170 pregnancies were detected in 161 women (incidence rate [IR]: 21.6/100 PY [95% confidence interval (CI): 18.5–25.2]). Of the 170 pregnancies, 105 (62%) were unplanned. Unmet need for contraception was 50% higher in women initiating ART in the past year as compared to women on ART>1 year (prevalence ratio 1.5 [95% CI: 1.1–2.0]); by two years post-ART initiation, nearly one quarter of women had at least one unplanned pregnancy. Cumulative incidence of pregnancy was equally high among recent ART initiators and ART experienced participants: 23.9% [95% CI: 16.4–34.1], 15.9% [12.0–20.8], and 21.0% [16.8–26.1] for women on ART 0–1 yr, >1 yr–2 yrs, and >2 yrs respectively (log-rank, p = 0.54). Eight hormonal contraceptive failures were detected [IR: 4.4 [95% CI: 2.2–8.9], 7/8 among women using injectable methods. Overall 47% (80/170) of pregnancies were not carried to term.

Conclusions

Rates of unintended pregnancies among women on ART are high, including women recently initiating ART with lower CD4 counts and higher viral loads. A substantial burden of pregnancy loss was observed. Integration of contraceptive services and counselling into ART care is necessary to reduce maternal and child health risks related to mistimed and unwanted pregnancies. Further research into injectable contraceptive failures on ART is warranted.     

Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women

Background

HIV prevention trials are increasingly being conducted in sub-Saharan Africa. Women at risk for HIV are also at risk of pregnancy. To maximize safety, women agree to avoid pregnancy during trials, yet pregnancies occur. Using data from the HVTN 503/“Phambili” vaccine trial, we report pregnancy incidence during and after the vaccination period and identify factors, measured at screening, associated with incident pregnancy.

Methods

To enrol in the trial, women agreed and were supported to avoid pregnancy until 1 month after their third and final vaccination (“vaccination period”), corresponding to the first 7 months of follow-up. Unsterilized women, pooled across study arms, were analyzed. Poisson regression compared pregnancy rates during and after the vaccination period. Cox proportional hazards regression identified associations with first pregnancy.

Results

Among 352 women (median age 23 yrs; median follow-up 1.5 yrs), pregnancy incidence was 9.6/100 women-years overall and 6.8/100 w-yrs and 11.3/100 w-yrs during and after the vaccination period, respectively [Rate Ratio = 0.60 (0.32–1.14), p = 0.10]. In multivariable analysis, pregnancy was reduced among women who: enrolled at sites providing contraception on-site [HR = 0.43, 95% CI (0.22–0.86)]; entered the trial as injectable contraceptive users [HR = 0.37 (0.21–0.67)] or as consistent condom users (trend) [HR = 0.54 (0.28–1.04)]. Compared with women with a single partner of HIV-unknown status, pregnancy rates were increased among women with: a single partner whose status was HIV-negative [HR = 2.34(1.16–4.73)] and; 2 partners both of HIV-unknown status [HR = 4.42(1.59–12.29)]. Women with 2 more of these risk factors: marijuana use, heavy drinking, or use of either during sex, had increased pregnancy incidence [HR = 2.66 (1.24–5.72)].

Conclusions

It is possible to screen South African women for pregnancy risk at trial entry. Providing injectable contraception for free on-site and supporting consistent condom use may reduce incident pregnancy. Screening should determine the substance use, partnering, and HIV status of both members of the couple for both pregnancy and HIV prevention.

Trial Registration

SA National Health Research Database DOH-27-0207-1539; Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00413725","term_id":"NCT00413725"}}NCT00413725     

Pregnancy Prevention and Condom Use Practices among HIV-Infected Women on Antiretroviral Therapy Seeking Family Planning in Lilongwe,Malawi

Background

Programs for integration of family planning into HIV care must recognize current practices and desires among clients to appropriately target and tailor interventions. We sought to evaluate fertility intentions, unintended pregnancy, contraceptive and condom use among a cohort of HIV-infected women seeking family planning services within an antiretroviral therapy (ART) clinic.

Methods

200 women completed an interviewer-administered questionnaire during enrollment into a prospective contraceptive study at the Lighthouse Clinic, an HIV/ART clinic in Lilongwe, Malawi, between August and December 2010.

Results

Most women (95%) did not desire future pregnancy. Prior reported unintended pregnancy rates were high (69% unplanned and 61% unhappy with timing of last pregnancy). Condom use was inconsistent, even among couples with discordant HIV status, with lack of use often attributed to partner’s refusal. Higher education, older age, lower parity and having an HIV negative partner were factors associated with consistent condom usage.

Discussion

High rates of unintended pregnancy among these women underscore the need for integ rating family planning, sexually transmitted infection (STI) prevention, and HIV services. Contraceptive access and use, including condoms, must be improved with specific efforts to enlist partner support. Messages regarding the importance of condom usage in conjunction with more effective modern contraceptive methods for both infection and pregnancy prevention must continue to be reinforced over the course of ongoing ART treatment.     

Barriers to the use of modern contraceptives and implications for woman-controlled prevention of sexually transmitted infections in Madagascar

Globally, unplanned pregnancies and sexually transmitted infections (STIs) persist as significant threats to women's reproductive health. Barriers to the use of modern contraceptives by women might inhibit uptake of novel woman-controlled methods for preventing STIs/HIV. Use of modern contraceptives and perceptions and attitudes towards contraceptive use were investigated among women in Antananarivo, Madagascar, using qualitative research. The hypothetical acceptability of the diaphragm--a woman-controlled barrier contraceptive device that also holds promise of protecting against STIs/HIV--was assessed. Women consecutively seeking care for vaginal discharge at a public health clinic were recruited for participation in a semi-structured interview (SSI) or focus group discussion (FGD). Audiotaped SSIs and FGDs were transcribed, translated and coded for predetermined and emerging themes. Of 46 participating women, 70% reported occasional use of male condoms, mostly for preventing pregnancy during their fertile days. Although women could name effective contraceptive methods, only 14% reported using hormonal contraception. Three barriers to use of modern contraceptives emerged: gaps in knowledge about the range of available contraceptive methods; misinformation and negative perceptions about some methods; and concern about social opposition to contraceptive use, mainly from male partners. These results demonstrate the need for programmes in both family planning and STI prevention to improve women's knowledge of modern contraceptives and methods to prevent STI and to dispel misinformation and negative perceptions of methods. In addition, involvement of men will probably be a critical component of increased uptake of woman-controlled pregnancy and STI/HIV prevention methods and improved health.     

Hospital Admission following Induced Abortion in Eastern Highlands Province,Papua New Guinea – A Descriptive Study

Background

In Papua New Guinea abortion is restricted under the Criminal Code Act. While safe abortions should available in certain situations, frequently they are not available to the majority of women. Sepsis from unsafe abortion is a leading cause of maternal mortality. Our findings form part of a wider, mixed methods study designed to identify complications requiring hospital treatment for post abortion care and to explore the circumstances surrounding unsafe abortion.

Methods

Through a six month prospective study we identified all women presenting to the Eastern Highlands Provincial Hospital following spontaneous and induced abortions. We undertook semi-structured interviews with women and reviewed individual case notes, extracting demographic and clinical information.

Findings

Case notes were reviewed for 56% (67/119) of women presenting for post abortion care. At least 24% (28/119) of these admissions were due to induced abortion. Women presenting following induced abortions were significantly more likely to be younger, single, in education at the time of the abortion and report that the baby was unplanned and unwanted, compared to those reporting spontaneous abortion. Obtained illegally, misoprostol was the method most frequently used to end the pregnancy. Physical and mechanical means and traditional herbs were also widely reported.

Conclusion

In a country with a low contraceptive prevalence rate and high unmet need for family planning, all reproductive age women need access to contraceptive information and services to avoid, postpone or space pregnancies. In the absence of this, women are resorting to unsafe means to end an unwanted pregnancy, putting their lives at risk and putting an increased strain on an already struggling health system. Women in this setting need access to safe, effective means of abortion.     

Unintended Pregnancies among Young Women Living in Urban Slums: Evidence from a Prospective Study in Nairobi City,Kenya

Background

Despite the significant proportion of young people residing in slum communities, little attention has been paid to the sexual and reproductive health (SRH) challenges they face during their transition to adulthood within this harsh environment. Little is known about the extent to which living in extreme environments, like slums, impact SRH outcomes, especially during this key developmental period. This paper aims to fill this research gap by examining the levels of and factors associated with unintended pregnancies among young women aged 15–22 in two informal settlements in Nairobi, Kenya.

Methods

We use data from two waves of a 3-year prospective survey that collected information from adolescents living in the two slums in 2007–2010. In total, 849 young women aged 15–22 were considered for analysis. We employed Cox and logistic regression models to investigate factors associated with timing of pregnancy experience and unintended pregnancy among adolescents who were sexually active by Wave 1 or Wave 2.

Findings

About two thirds of sexually experienced young women (69%) have ever been pregnant by Wave 2. For 41% of adolescents, the pregnancies were unintended, with 26% being mistimed and 15% unwanted. Multivariate analysis shows a significant association between a set of factors including age at first sex, schooling status, living arrangements and timing of pregnancy experience. In addition, marital status, schooling status, age at first sex and living arrangements are the only factors that are significantly associated with unintended pregnancy among the young women.

Conclusions

Overall, this study underscores the importance of looking at reproductive outcomes of early sexual initiation, the serious health risks early fertility entail, especially among out-of school girls, and sexual activity in general among young women living in slum settlements. This provides greater impetus for addressing reproductive behaviors among young women living in resource-poor settings such as slums.     

Determinants of breastfeeding initiation among mothers in Sydney,Australia: findings from a birth cohort study

Background

Breastfeeding has short-term and long-term benefits for both the infant and the mother. The objective of this study was to identify the incidence of breastfeeding initiation among women in South Western Sydney, and the factors associated with the initiation of breastfeeding.

Methods

Child and Family Health Nurses recruited mother-infant dyads (n = 1035) to the Healthy Smiles Healthy Kids birth study in South Western Sydney, an ethnically and socio-economically diverse area, at the first post-natal home visit. A sample of 935 women completed a structured, interviewer-administered questionnaire at 8 weeks. Multivariate logistic regression analysis was used to identify those factors independently associated with the initiation of breastfeeding.

Results

In total, 92% of women (n = 860) commenced breastfeeding in hospital. Women who completed a university degree were more likely to initiate breastfeeding compared to those who did not complete high school (AOR = 7.16, 95% CI 2.73, 18.79). Vietnamese women had lower odds of breastfeeding initiation compared to Australian born women (AOR = 0.34. 95% CI 0.13, 0.87). Women who had more than one child were less likely to breastfeed than those who had one child (AOR = 0.38, 95% CI 0.19, 0.79). Women who gave birth via a caesarean section were less likely to breastfeed their baby compared to those who had a vaginal delivery (AOR = 0.27, 95% CI 0.14, 0.52). Women who drank alcohol during pregnancy had 72% lower odds to breastfeed compared to those who did not drink alcohol during pregnancy (AOR = 0.28, 95% CI 0.11, 0.71). Women who reported that their partner preferred breastfeeding were more likely to initiate breastfeeding (AOR = 11.77, 95% CI 5.73, 24.15) and women who had chosen to breastfeed before pregnancy had more than 2.5 times the odds of breastfeeding their baby compared to those women who made their decision either during pregnancy or after labour (AOR = 2.80, 95% CI 1.31, 5.97).

Conclusions

Women with lower levels of education, who consume alcohol during pregnancy, have more than one child, and make infant feeding decision after becoming pregnant, and those born in Vietnam should be targeted when implementing breastfeeding promotion programs. Further, women who deliver by caesarean section require additional breastfeeding support post-delivery and it is important to include fathers in breastfeeding related decisions and encourage them to participate in antenatal programs.

     

Is there a link between blastomere contact surfaces of day 3 embryos and live birth rate?

Background

Limitations in our current knowledge of normative physiologic changes in thyroid function during the periconception window narrow our ability to establish an optimal approach to screening and diagnosis of thyroid disease in pregnant women. The objective of this study was to characterize changes in thyroid function during the transition from the pre-pregnant to pregnant state in normal fertile women.

Methods

Women (N = 60) ages 30-42 years without a history of thyroid disease, who were planning pregnancy, were observed prospectively before and during early pregnancy. Thyroid function (thyroid stimulating hormone, TSH and free thyroxine, FT4) was measured before conception and between 6 and 9 weeks gestation. Pre-pregnancy samples were analyzed for thyroid antibodies. Bivariate analyses and longitudinal curves (general estimating equation models) were used to analyze changes in thyroid function during the periconception window by antibody status.

Results

Pre-pregnancy TSH values were significantly higher than early pregnancy TSH (p < 0.001), but FT4 values did not differ (p = 0.53). TSH declined as gestational age increased (P < 0.01). Thyroid antibody positive women had a higher pre-pregnancy TSH compared to antibody negative women (p < 0.01). Periconceptional change in thyroid function was more variable among women with antibodies (p < 0.001). 50% of women with elevated pre-pregnancy TSH values (TSH > 3.0 mIU/L) had normal TSH values (TSH < 2.5 mIU/L) in pregnancy.

Conclusions

TSH values decline during the transition from pre-pregnancy to early pregnancy. The change in TSH appears to be less predictable in women with thyroid antibodies. Periconceptional changes in thyroid function should be considered in formulating prenatal thyroid screening guidelines.     

Association between -238 but not -308 polymorphism of Tumor necrosis factor alpha (TNF-alpha)v and unexplained recurrent spontaneous abortion (URSA) in Chinese population

Objectives

TNF-alpha is a critical cytokine produced by Th1 cells while altered T helper 1 (Th1)-Th2 balance is found crucial for a successful pregnancy.

Study Design

A cohort of 132 Southern Chinese Han RSA patients and 152 controls constituted the subjects of this study. Two functional polymorphisms -308 and -238 of TNF-alpha were studied by association analysis.

Results

lack of association was found in TNF-alpha -308 SNP yet a significant difference was discovered in -238 polymorphism.

Conclusion

This study suggested that TNF-alpha may be a risk factor in Chinese RSA patients. However the ethnic differences may also contribute to the results.     

In vitro activities of novel 4-HPR derivatives on a panel of rhabdoid and other tumor cell lines

Background

Natural killer (NK) cells are an important resource of the innate immune system directly involved in the spontaneous recognition and lysis of virus-infected and tumor cells. An exquisite balance of inhibitory and activating receptors tightly controls the NK cell activity. At present, one of the best-characterized activating receptors is NKG2D, which promotes the NK-mediated lysis of target cells by binding to a family of cell surface ligands encoded by the MHC class I chain-related (MIC) genes, among others. The goal of this study was to describe the expression pattern of MICA and MICB at the molecular and cellular levels in human cervical cancer cell lines infected or not with human papillomavirus, as well as in a non-tumorigenic keratinocyte cell line.

Results

Here we show that MICA and MICB exhibit differential expression patterns among HPV-infected (SiHa and HeLa) and non-infected cell lines (C33-A, a tumor cell line, and HaCaT, an immortalized keratinocyte cell line). Cell surface expression of MICA was higher than cell surface expression of MICB in the HPV-positive cell lines; in contrast, HPV-negative cells expressed lower levels of MICA. Interestingly, the MICA levels observed in C33-A cells were overcome by significantly higher MICB expression. Also, all cell lines released higher amounts of soluble MICB than of soluble MICA into the cell culture supernatant, although this was most pronounced in C33-A cells. Additionally, Real-Time PCR analysis demonstrated that MICA was strongly upregulated after genotoxic stress.

Conclusions

This study provides evidence that even when MICA and MICB share a high degree of homology at both genomic and protein levels, differential regulation of their expression and cell surface appearance might be occurring in cervical cancer-derived cells.     

Associated Risk Factors of STIs and Multiple Sexual Relationships among Youths in Malawi

Background

Having unprotected sex with multiple sexual partners (MSP) is the greatest risk factor for human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) among youths. Young people with MSPs are less likely to use a condom and the greater the risk for STIs. This study examines the associated risk factors of STIs and multiple sexual partnerships among youths aged 15–24 years.

Data and Methods

The Malawi Demographic Health Survey 2010 data was used. Out of a sample of 2,987 males and 9,559 females aged 15–24 years, 2,026 males and 6,470 females were considered in the study. Chi square test and logistic regression techniques were performed. Analysis was performed using Statistical Package for Social Sciences (SPSS) version 22.

Findings

The results indicate that 1,399 (69.0%) males and 2,290 (35.4%) females reported multiple sexual partnerships (MSP). Within the rural area, females (n = 1779) were more likely to report MSP than males (n = 1082) and within the urban areas, a higher proportion of females (n = 511) still reported MSP, with males (n = 316). About 78% rural females aged 20–24 years, and about 79% rural males aged 15–19 years reported MSP. The likelihood of MSP was higher among females in the poorest households (OR = 1.31), being married (OR = 5.71) and Catholic males (OR = 1.63), who were married (OR = 1.59). Catholic males (OR = 1.82) in the rural areas, who were married (OR = 1.80) and rural females in the northern region (OR = 1.26) were more likely to have MSP. The odds ratios were higher among urban females in the poorest (OR = 3.45) households who were married (OR = 4.22).

Conclusions

Having more than one sexual partner increases the risk of STIs and sexuality education programs should be introduced that emphasize the danger that surrounds MSP.     

Factors associated with uptake of post-abortion family planning in Shire town,Tigray, Ethiopia

Objectives

Post-abortion contraceptive service is pivotal for the prevention of unwanted pregnancy and alleviation of its complication. Worldwide half of the pregnancy is unplanned, whereas unwanted pregnancy ends up with abortion. This study assessed post-abortion contraceptive uptake and associated factors among abortion service users at health institution in Shire town, North Ethiopia. Institutional based cross-sectional study was conducted from December 15/2016 to March 15, 2017, in Shire town. Data were collected using systematic random sampling technique. Bivariate and multivariable analyses were done to determine the association of each independent variable with the dependent variable.

Results

Overall post-abortion contraceptive utilization in this study was 61.5%. Married [AOR 2.59, 95% CI (1.16, 5.65)], completed College education [AOR 5.69, 95% CI (1.61, 20.11)], previous contraceptive used [AOR 3.62, 95% CI (1.77, 7.40)], counseling of family planning [AOR 3.53 95% CI (1.69, 7.37)], grand multipara [AOR 7.91, 95% CI (1.66, 37.74)] and public health institution [AOR 5.95, 95% CI (3.03, 11.72)] were significantly associated with the post-abortion contraceptive utilization. In this study, post-abortion contraceptive utilization was about two-third. Being married, had been completing a college education, had been receiving family planning counseling, previous contraceptive usage, abortion care service at public health institution, and being grand multiparty were determinants of post-abortion contraceptive utilization.

     

Proteasome Modulator 9 SNPs are linked to hypertension in type 2 diabetes families

Background

N-terminal-pro-brain natriuretic peptide (NT-proBNP) is elevated in gestational hypertension and preeclampsia. This trial aimed to generate data for gestational diabetes mellitus patients, who are at risk to develop these complications.

Methods

We have measured NT-proBNP in 223 otherwise healthy women between gestational week 24 and 32 referred to the outpatient diabetes unit in a cross-sectional study.

Results

88 control subjects, 45 patients with indication for medical nutrition therapy (MNT) alone and 90 patients who required insulin therapy were included. Groups of women were comparable regarding gestational week. Body mass index before pregnancy and at blood draw was significantly higher in subjects with insulin dependent gestational diabetes mellitus compared to MNT controlled gestational diabetes mellitus. NT-proBNP was significantly lower in patients with insulin dependent gestational diabetes mellitus (35 ± 25 pg/ml) compared to controls (53 ± 43 pg/ml, p = 0.012).

Conclusions

NT-proBNP is within the reference range of normal subjects in women with gestational diabetes mellitus. Differences in body mass index, changes in glomerular filtration rate and haemodynamics may explain lower NT-proBNP concentrations in insulin dependent gestational diabetes mellitus. A false negative interpretation needs to be considered in these women.     

Pregnancy Incidence and Risk Factors among Women Participating in Vaginal Microbicide Trials for HIV Prevention: Systematic Review and Meta-Analysis

Introduction

Pregnancy is contraindicated in vaginal microbicide trials for the prevention of HIV infection in women due to the unknown maternal and fetal safety of the microbicides. Women who become pregnant are taken off the microbicide during pregnancy period but this result in reduction of the power of the trials. Strategies to reduce the pregnancy rates require an understanding of the incidence and associated risk factors of pregnancy in microbicide trials. This systematic review estimates the overall incidence rate of pregnancy in microbicide trials and describes the associated risk factors.

Methods

A comprehensive literature search was carried out to identify eligible studies from electronic databases and other sources. Two review authors independently selected studies and extracted relevant data from included studies. Meta-analysis of incidence rates of pregnancy was carried out and risk factors of pregnancy were reported narratively.

Results

Fifteen studies reporting data from 10 microbicide trials (N=27,384 participants) were included. A total of 4,107 participants (15.0%) fell pregnant and a meta-analysis of incidence rates of pregnancy from 8 microbicide trials (N=25,551) yielded an overall incidence rate of 23.37 (95%CI: 17.78 to 28.96) pregnancies per 100 woman-years. However, significant heterogeneity was detected. Hormonal injectable, intra-uterine device (IUD) or implants or sterilization, older age, more years of education and condom use were associated with lower pregnancy. On the other hand, living with a man, history of pregnancy, self and partner desire for future baby, oral contraceptive use, increased number of unprotected sexual acts and inconsistent use of condoms were associated with higher pregnancy.

Conclusions

The incidence rate of pregnancy in microbicide trials is high and strategies for its reduction are urgently required in order to improve the sample size and power of these trials.     

Pregnancy and virologic response to antiretroviral therapy in South Africa

Background

Although women of reproductive age are the largest group of HIV-infected individuals in sub-Saharan Africa, little is known about the impact of pregnancy on response to highly active antiretroviral therapy (HAART) in that setting. We examined the effect of incident pregnancy after HAART initiation on virologic response to HAART.

Methods and Findings

We evaluated a prospective clinical cohort of adult women who initiated HAART in Johannesburg, South Africa between 1 April 2004 and 30 September 2009, and followed up until an event, death, transfer, drop-out, or administrative end of follow-up on 31 March 2010. Women over age 45 and women who were pregnant at HAART initiation were excluded from the study; final sample size for analysis was 5,494 women. Main exposure was incident pregnancy, experienced by 541 women; main outcome was virologic failure, defined as a failure to suppress virus to ≤400 copies/ml by six months or virologic rebound >400 copies/ml thereafter. We calculated adjusted hazard ratios using marginal structural Cox proportional hazards models and weighted lifetable analysis to calculate adjusted five-year risk differences. The weighted hazard ratio for the effect of pregnancy on time to virologic failure was 1.34 (95% confidence limit [CL] 1.02, 1.78). Sensitivity analyses generally confirmed these main results.

Conclusions

Incident pregnancy after HAART initiation was associated with modest increases in both relative and absolute risks of virologic failure, although uncontrolled confounding cannot be ruled out. Nonetheless, these results reinforce that family planning is an essential part of care for HIV-positive women in sub-Saharan Africa. More work is needed to confirm these findings and to explore specific etiologic pathways by which such effects may operate.