Evidence map›Paper›PMID 32360666›Full record

ArticleContraception2020

Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India.

Malabika Roy, Avishek Hazra, Ruth Merkatz, Marlena Plagianos, Mohcine Alami, L N Gaur, Kumudha Aruldas, Heather Sussman, Bruce Variano, Regine Sitruk-Ware and 1 more

Open access · greenAbstract readEquivalence TrialMulticenter Study
In one paragraph

Article in Contraception, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 4 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 4 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Malabika RoyIndian Council of Medical Research, Ansari Nagar, New Delhi, India. Electronic address: malaroy69@gmail.com.
Avishek HazraPopulation Council, Zone 5A, India Habitat Centre, New Delhi, India.
Ruth MerkatzCenter for Biomedical Research, Population Council, New York, NY, USA.
Marlena PlagianosCenter for Biomedical Research, Population Council, New York, NY, USA.
Mohcine AlamiCenter for Biomedical Research, Population Council, New York, NY, USA.
L N GaurIndian Council of Medical Research, Ansari Nagar, New Delhi, India.
Kumudha AruldasPopulation Council, Zone 5A, India Habitat Centre, New Delhi, India.
Heather SussmanCenter for Biomedical Research, Population Council, New York, NY, USA.
Bruce VarianoCenter for Biomedical Research, Population Council, New York, NY, USA.
Regine Sitruk-WareCenter for Biomedical Research, Population Council, New York, NY, USA.
Progesterone Vaginal Ring Study Group at Participating CentersGovernment Medical College, SMGS Hospital, Jammu, India; Postgraduate Institute of Medical Education and Research Chandigarh, India; Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India; K.G. Medical University, Lucknow, India; Motilal Nehru Medical College and Hospital, Prayagraj, India; GSVM Medical College and Hospital, Kanpur, India; SMS Medical College and Zanana Hospital, Jaipur, India; Institute of Obstetrics and Gynecology, Madras Medical College, Chennai, India; Government Medical College and SAT Hospital, Thiruvananthapuram, India; Jawaharlal Nehru Medical College and Hospital, Belagavi, India; Patna Medical College and Hospital, Patna, India; R.G. Kar Medical College and Hospital, Kolkata, India; Medical College and Eden Hospital, Kolkata, India; SCB Medical College and Hospital, Cuttack, India; Seth GS Medical College and KEM Hospital, Mumbai, India; KEM Hospital, Pune, India; Grant Medical College and Sir JJ Group of Hospitals, Mumbai, India; Goa Medical College and Hospital, Goa, India; Indian Council of Medical Research - National Institute for Research in Reproductive Health, Mumbai, India.
Population Council · USIndian Council of Medical Research · INPopulation Council · IN

Funding

Evaluation of a progesterone vaginal ring as a new contraceptive option in IndiaR01HD061106 · NICHD · POPULATION COUNCIL · PI ROY, MALABIKA, WARE, REGINE SITRUK · 2010 to 2013
$1.3M
NICHD NIH HHS R01 HD061106
6 · The paper itself

Abstract

objectivesEvaluate 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. STUDY

designWe 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.

resultsWe 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.

conclusionsEfficacy 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. IMPLICATIONS: 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.

Indexed as

Contraceptive Devices, FemaleIntrauterine Devices, CopperContraceptive AgentsFemaleHumansInfantLactationMothersPregnancyProgesteroneContraceptive AgentsProgesteroneContinuation rateLactational amenorrheaPostpartum contraceptionProgesterone vaginal ringUser-controlled

Identifiers

PMID32360666
PMCPMC7483628
OpenAlexW3021418092

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.