BACKGROUND: A trial of progesterone to prevent preterm birth among HIV-infected Zambian women [Improving Pregnancy Outcomes with Progesterone (IPOP)] found no treatment effect, but the risk of the primary outcome was among the lowest ever documented in women with HIV. In this secondary analysis, we compare the risks of preterm birth (<37 weeks), stillbirth, and a composite primary outcome comprising the two in IPOP versus an observational pregnancy cohort [Zambian Preterm Birth Prevention Study (ZAPPS)] in Zambia, to evaluate reasons for the low risk in IPOP. METHODS: Both studies enrolled women before 24 gestational weeks, during August 2015-September 2017 (ZAPPS) and February 2018-January 2020 (IPOP). We used linear probability and log-binomial regression to estimate risk differences and risk ratios (RR), before and after restriction and standardization with inverse probability weights. RESULTS: The unadjusted risk of composite outcome was 18% in ZAPPS (N = 1450) and 9% in IPOP (N = 791) (RR = 2.0; 95% CI = 1.6, 2.6). After restricting and standardizing the ZAPPS cohort to the distribution of IPOP baseline characteristics, the risk remained higher in ZAPPS (RR = 1.6; 95% CI = 1.0, 2.4). The lower risk of preterm/stillbirth in IPOP was only partially explained by measured risk factors. CONCLUSIONS: Possible benefits in IPOP of additional monetary reimbursement, more frequent visits, and group-based care warrant further investigation.
BACKGROUND: A trial of progesterone to prevent preterm birth among HIV-infected Zambian women [Improving Pregnancy Outcomes with Progesterone (IPOP)] found no treatment effect, but the risk of the primary outcome was among the lowest ever documented in women with HIV. In this secondary analysis, we compare the risks of preterm birth (<37 weeks), stillbirth, and a composite primary outcome comprising the two in IPOP versus an observational pregnancy cohort [Zambian Preterm Birth Prevention Study (ZAPPS)] in Zambia, to evaluate reasons for the low risk in IPOP. METHODS: Both studies enrolled women before 24 gestational weeks, during August 2015-September 2017 (ZAPPS) and February 2018-January 2020 (IPOP). We used linear probability and log-binomial regression to estimate risk differences and risk ratios (RR), before and after restriction and standardization with inverse probability weights. RESULTS: The unadjusted risk of composite outcome was 18% in ZAPPS (N = 1450) and 9% in IPOP (N = 791) (RR = 2.0; 95% CI = 1.6, 2.6). After restricting and standardizing the ZAPPS cohort to the distribution of IPOP baseline characteristics, the risk remained higher in ZAPPS (RR = 1.6; 95% CI = 1.0, 2.4). The lower risk of preterm/stillbirth in IPOP was only partially explained by measured risk factors. CONCLUSIONS: Possible benefits in IPOP of additional monetary reimbursement, more frequent visits, and group-based care warrant further investigation.
Authors: Jennifer Y Chen; Heather J Ribaudo; Sajini Souda; Natasha Parekh; Anthony Ogwu; Shahin Lockman; Kathleen Powis; Scott Dryden-Peterson; Tracy Creek; William Jimbo; Tebogo Madidimalo; Joseph Makhema; Max Essex; Roger L Shapiro Journal: J Infect Dis Date: 2012-10-12 Impact factor: 5.226
Authors: Shayna D Cunningham; Jessica B Lewis; Fatma M Shebl; Lisa M Boyd; Marc A Robinson; Stephanie A Grilo; Susan M Lewis; Anne L Pruett; Jeannette R Ickovics Journal: J Womens Health (Larchmt) Date: 2018-09-25 Impact factor: 2.681
Authors: Joan T Price; Bellington Vwalika; Jessie K Edwards; Stephen R Cole; Margaret P Kasaro; Katelyn J Rittenhouse; Andrew Kumwenda; Mwansa K Lubeya; Jeffrey S A Stringer Journal: J Acquir Immune Defic Syndr Date: 2021-06-01 Impact factor: 3.771
Authors: A T Papageorghiou; S H Kennedy; L J Salomon; E O Ohuma; L Cheikh Ismail; F C Barros; A Lambert; M Carvalho; Y A Jaffer; E Bertino; M G Gravett; D G Altman; M Purwar; J A Noble; R Pang; C G Victora; Z A Bhutta; J Villar Journal: Ultrasound Obstet Gynecol Date: 2014-11-02 Impact factor: 7.299
Authors: Jody R Lori; Meagan Chuey; Michelle L Munro-Kramer; Henrietta Ofosu-Darkwah; Richard M K Adanu Journal: Reprod Health Date: 2018-12-17 Impact factor: 3.223
Authors: Rebecca Zash; Denise L Jacobson; Modiegi Diseko; Gloria Mayondi; Mompati Mmalane; Max Essex; Tendani Gaolethe; Chipo Petlo; Shahin Lockman; Lewis B Holmes; Joseph Makhema; Roger L Shapiro Journal: Lancet Glob Health Date: 2018-06-04 Impact factor: 26.763
Authors: Lindsay Grenier; Stephanie Suhowatsky; Mark M Kabue; Lisa M Noguchi; Diwakar Mohan; Shalmali Radha Karnad; Brenda Onguti; Eunice Omanga; Anthony Gichangi; Jonesmus Wambua; Charles Waka; Jaiyeola Oyetunji; Jeffrey M Smith Journal: PLoS One Date: 2019-10-02 Impact factor: 3.240