Evidence map›Paper›PMID 22436198›Full record

Trial reportSexually transmitted infections2012

Pregnancy and contraceptive use among women participating in an HIV prevention trial in Tanzania.

Aderonke Odutola, Kathy Baisley, Richard J Hayes, Mary Rusizoka, Clare Tanton, Helen A Weiss, John Changalucha, David A Ross, Deborah Watson-Jones

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sexually transmitted infections, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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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

9 authors at 4 institutions in 2 countries.

Aderonke OdutolaFaculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel St., London WC1E 7HT, UK. deborah.watson-jones@lshtm.ac.uk
Kathy Baisley
Richard J Hayes
Mary Rusizoka
Clare Tanton
Helen A Weiss
John Changalucha
David A Ross
Deborah Watson-Jones
London School of Hygiene & Tropical Medicine · GBAmref Health Africa · TZThe Francis Crick Institute · GBUniversity of London · GB

Funding

Medical Research Council G0700837Wellcome Trust
6 · The paper itself

Abstract

objectivesInformation on pregnancy rates and factors associated with pregnancy and contraceptive use is important for clinical trials in women in sub-Saharan Africa where withdrawal of investigational products may be required in the event of pregnancy with a consequent effect on sample size and trial power.

methodsA prospective cohort analysis of pregnancy and contraceptive use was conducted in Tanzanian women enrolled in a randomised placebo-controlled trial of herpes simplex virus-suppressive therapy with acyclovir to measure the effect on HIV incidence in HIV-negative women and on genital and plasma HIV viral load in HIV-positive women. The cohort was followed every 3 months for 12-30 months. Women at each visit were categorised into users or non-users of contraception. Pregnancy rates and factors associated with pregnancy incidence and contraceptive use were measured.

resultsOverall 254 of 1305 enrolled women became pregnant at least once during follow-up (pregnancy rate: 12.0/100 person-years). Younger age, being unmarried, higher baseline parity and changes in contraceptive method during follow-up were independently associated with pregnancy. Having paid sex and being HIV positive were associated with lower risk of pregnancy. Uptake of contraception was associated with young age, being unmarried, occupation, parity and the number and type of sexual partners.

conclusionsData on use of contraceptive methods and risk factors for pregnancy can help to guide decisions on trial eligibility and the need for additional counselling. Mandatory reliable contraceptive use in study participants may be required to reduce pregnancy rates in studies where pregnancy is contraindicated.

Indexed as

Pregnancy RateAcyclovirAdolescentAdultAntiviral AgentsCohort StudiesContraceptive AgentsDrug UtilizationFemaleHerpes SimplexHIV InfectionsHumansPlacebosPregnancyProspective StudiesTanzaniaAcyclovirAntiviral AgentsContraceptive AgentsPlacebos

Identifiers

PMID22436198
PMCPMC3461760
OpenAlexW2131957317

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.