255 Community Level Interventions for Pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial

• Published in: Pregnancy hypertension 2018-10, Vol.13, p.S36-S36
• Main Authors: Sevene, Esperança, Munguambe, Khátia, Sacoor, Charfudin, Vala, Anifa, Boene, Helena, Sharma, Sumedha, Bone, Jeffrey, Payne, Beth A., Vidler, Marianne, Li, Jing, Tu, Domena K., Lee, Tang, Ansermino, Mark A., Dunsmuir, Dustin T., Singer, Joel, Tchavana, Corssino, Shennan, Andrew, Nathan, Hannah, Macete, Eusébio, Bhutta, Zulfiqar A., Magee, Laura A., von Dadelszen, Peter, Clip Trials Working Group
• Format: Article
• Language: English
• ISSN: 2210-7789; 2210-7797
• DOI: 10.1016/j.preghy.2018.08.106

Hypertensive disorders of pregnancy (HDP) contribute to 35.8% of maternal mortality in Mozambique. Community-level early detection and initial management of HDP by agentes polivalentes elementares (APEs) could prevent adverse pregnancy events. To reduce by 20%, one or more of: maternal death/morbidity, stillbirth, or neonatal death/morbidity in intervention clusters. The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, APEs-led mobile health-guided clinical assessment and initial treatment (MgSO4 or methyldopa), and referral to facility, as appropriate. Data were collected in all clusters by six-monthly household surveillance. Treatment effect was estimated by multilevel logistic regression adjusting for baseline cluster- and individual-level factors of prognostic significance. A priori-defined secondary analyses included evaluation of temporal and dose-dependent treatment effects. Of 15,224 pregnancies (7980 intervention, 7244 control), losses to follow-up were 1.9% and 2.7%, respectively. The primary outcome did not differ between intervention and control clusters (1387, 17.4% vs. 1289, 17.8%; adjusted odds ratio [aOR] 1.34, 95% confidence interval [CI] [0.71–2.51]; p = 0.36). In both arms, the odds of primary outcome decreased by an estimated 8.0% every quarter (OR = 0.92, 95% CI [0.93-0.94], p