Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India.
Continuation rate
Lactational amenorrhea
Postpartum contraception
Progesterone vaginal ring
User-controlled
Journal
Contraception
ISSN: 1879-0518
Titre abrégé: Contraception
Pays: United States
ID NLM: 0234361
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
20
12
2019
revised:
18
04
2020
accepted:
21
04
2020
pubmed:
4
5
2020
medline:
16
10
2021
entrez:
4
5
2020
Statut:
ppublish
Résumé
Evaluate and compare contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA) in married lactating women (20-35 years) using the progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD) during the first postpartum year. We conducted a one-year multicenter, non-randomized, non-inferiority, open-label, comparative trial at 20 centers in India and compared efficacy, safety, continuation and LA plus feeding patterns and growth/well-being of participants' infants. Women used four 3-month PVRs consecutively (lost PVRs were not replaced) and were to breastfeed at least four times/day. We used Pearl Index (PI) and Kaplan Meier (K-M) rates to analyze pregnancy and K-M for continuation. We enrolled 789 women (459 PVR, 330 IUD). Neither PI nor K-M one-year pregnancy rates differed significantly between groups (PI: PVR-0.62; IUD-0.35); (K-M: PVR-0.7; IUD-0.4, p = 0.58). Continuation rates at 12 months were 78.5% (IUD) vs. 56.9% (PVR) (p < 0.001). Ring expulsions and menorrhagia were the most common discontinuation among PVR/IUD users respectively. The median duration of LA among PVR vs. IUD users was 405 vs. 120 days (p < 0.001). Both groups reported similar adverse events (PVR: 24.2%; IUD: 23.0%); there were no serious adverse events among PVR users. Infants from both groups fed 12-7 times/day and grew at expected rates. Efficacy and safety outcomes were comparable among women in both groups. Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users. Infant breastfeeding and growth patterns/well-being were favorable in both groups. PVR, a user-controlled device, offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being.
Identifiants
pubmed: 32360666
pii: S0010-7824(20)30131-1
doi: 10.1016/j.contraception.2020.04.016
pmc: PMC7483628
mid: NIHMS1589636
pii:
doi:
Substances chimiques
Contraceptive Agents
0
Progesterone
4G7DS2Q64Y
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
159-167Subventions
Organisme : NICHD NIH HHS
ID : R01 HD061106
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
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