دورية أكاديمية
Vaginal progesterone to prevent preterm delivery among HIV-infected pregnant women in Zambia: A feasibility study.
| العنوان: | Vaginal progesterone to prevent preterm delivery among HIV-infected pregnant women in Zambia: A feasibility study. |
|---|---|
| المؤلفون: | Price JT; Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.; Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia., Phiri WM; UNC Global Projects - Zambia, Lusaka, Zambia., Freeman BL; Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America., Vwalika B; Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia., Winston J; Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America., Mabula-Bwalya CM; UNC Global Projects - Zambia, Lusaka, Zambia., Mulenga HB; Pharmaceutical Society of Zambia, Lusaka, Zambia., Stringer JSA; Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America. |
| المصدر: | PloS one [PLoS One] 2020 Jan 29; Vol. 15 (1), pp. e0224874. Date of Electronic Publication: 2020 Jan 29 (Print Publication: 2020). |
| نوع المنشور: | Journal Article; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: San Francisco, CA : Public Library of Science |
| مواضيع طبية MeSH: | HIV Infections/*drug therapy , Premature Birth/*drug therapy , Progesterone/*administration & dosage , Vagina/*drug effects, Administration, Intravaginal ; Adult ; Cervical Length Measurement ; Cervix Uteri/drug effects ; Cervix Uteri/physiopathology ; Cervix Uteri/virology ; Feasibility Studies ; Female ; HIV Infections/epidemiology ; HIV Infections/prevention & control ; HIV Infections/virology ; Humans ; Infant, Newborn ; Pregnancy ; Pregnancy, Multiple ; Premature Birth/epidemiology ; Premature Birth/physiopathology ; Vagina/physiopathology ; Vagina/virology ; Zambia/epidemiology |
| مستخلص: | Antenatal vaginal progesterone (VP) reduces the risk of preterm birth (PTB) in women with shortened cervical length, and we hypothesize that it may also prevent PTB in women with HIV as their primary risk factor. We conducted a pilot feasibility study in Lusaka, Zambia to investigate uptake, adherence, and retention in preparation for a future efficacy trial. This was a double-masked, placebo-controlled, randomized trial of 200mg daily self-administered VP suppository or placebo. Pregnant women with HIV who were initiating or continuing antiretroviral therapy were eligible for participation. Potential participants underwent ultrasound to assess eligibility; we excluded those ≥24 gestational weeks, with non-viable, multiple gestation, or extrauterine pregnancies, with short cervix (<2.0cm), or with prior spontaneous PTB. Participants initiated study product between 20-24 weeks of gestation and continued to 37 weeks (or delivery, if sooner). The primary outcome was adherence (proportion achieving ≥80% study product use), assessed by dye stain assay of returned single-use vaginal applicators. Secondary outcomes with pre-defined feasibility targets were: uptake (≥50% eligible participants enrolled) and retention (≥90% ascertainment of delivery outcomes). We also evaluated preliminary efficacy by comparing the risk of spontaneous PTB <37 weeks between groups. From July 2017 to June 2018, 208 HIV-infected pregnant women were eligible for screening and 140 (uptake = 67%) were randomly allocated to VP (n = 70) or placebo (n = 70). Mean adherence was 94% (SD±9.4); 91% (n = 125/137) achieved overall adherence ≥80%. Delivery outcomes were ascertained from 134 (96%) participants. Spontaneous PTB occurred in 10 participants (15%) receiving placebo and 8 (12%) receiving progesterone (RR 0.82; 95%CI:0.34-1.97). Spontaneous PTB < 34 weeks occurred in 6 (9%) receiving placebo and 4 (6%) receiving progesterone (RR 0.67; 95%CI:0.20-2.67). In contrast to findings from vaginal microbicide studies in HIV-uninfected, non-pregnant women, our trial participants were highly adherent to daily self-administered vaginal progesterone. The study's a priori criteria for uptake, adherence, and retention were met, indicating that a phase III efficacy trial would be feasible. Competing Interests: The authors have declared that no competing interests exist. |
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| معلومات مُعتمدة: | D43 TW010558 United States TW FIC NIH HHS; R21 HD090987 United States HD NICHD NIH HHS; P30 AI050410 United States AI NIAID NIH HHS; K01 TW010857 United States TW FIC NIH HHS; T32 HD075731 United States HD NICHD NIH HHS |
| المشرفين على المادة: | 4G7DS2Q64Y (Progesterone) |
| تواريخ الأحداث: | Date Created: 20200130 Date Completed: 20200331 Latest Revision: 20200331 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC6988922 |
| DOI: | 10.1371/journal.pone.0224874 |
| PMID: | 31995557 |
| قاعدة البيانات: | MEDLINE |
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