Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster-randomized stepped-wedge trial

David Canning, Iqbal H Shah, Erin Pearson, Elina Pradhan, Mahesh Karra, Leigh Senderowicz, Till Bärnighausen, Donna Spiegelman, Ana Langer, David Canning, Iqbal H Shah, Erin Pearson, Elina Pradhan, Mahesh Karra, Leigh Senderowicz, Till Bärnighausen, Donna Spiegelman, Ana Langer

Abstract

Background: During the year following the birth of a child, 40% of women are estimated to have an unmet need for contraception. The copper IUD provides safe, effective, convenient, and long-term contraceptive protection that does not interfere with breastfeeding during the postpartum period. Postpartum IUD (PPIUD) insertion should be performed by a trained provider in the early postpartum period to reduce expulsion rates and complications, but these services are not widely available. The International Federation of Obstetricians and Gynecologists (FIGO) will implement an intervention that aims to institutionalize PPIUD training as a regular part of the OB/GYN training program and to integrate it as part of the standard practice at the time of delivery in intervention hospitals.

Methods: This trial uses a cluster-randomized stepped wedge design to assess the causal effect of the FIGO intervention on the uptake and continued use of PPIUD and of the effect on subsequent pregnancy and birth. This trial also seeks to measure institutionalization of PPIUD services in study hospitals and diffusion of these services to other providers and health facilities. This study will also include a nested mixed-methods performance evaluation to describe intervention implementation.

Discussion: This study will provide critical evidence on the causal effects of hospital-based PPIUD provision on contraceptive choices and reproductive health outcomes, as well as on the feasibility, acceptability and longer run institutional impacts in three low- and middle-income countries.

Trial registration: Trial registered on March 11, 2016 with ClinicalTrials.gov, NCT02718222 .

Keywords: IUD; Impact evaluation; Postpartum contraception.

Figures

Fig. 1
Fig. 1
SPIRIT Flow Diagram for Tanzania: PPIUD study quantitative data collection by hospital group
Fig. 2
Fig. 2
SPIRIT Flow Diagram for Nepal and Sri Lanka: PPIUD study quantitative data collection by hospital group

References

    1. Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80:327–336. doi: 10.1016/j.contraception.2009.03.024.
    1. Rossier C, Bradley SEK, Ross J, Winfrey W. Reassessing Unmet Need for Family Planning in the Postpartum Period. Stud Fam Plann. 2015;46(4):355–367. doi: 10.1111/j.1728-4465.2015.00037.x.
    1. Winfrey W, Kshitiz R. Use of Family Planning in Postpartum Period. 2014, 36.
    1. World Health Organization (WHO). Medical Eligibility Criteria for Contraceptive use: Fourth Edition, 2009. 2010.
    1. Grimes DA, Lopez LM, Schulz KF. Van Vilet HAAM. Stanwood NL: Immediate post-partum insertion of intrauterine devices. Cochrane Database of Systematic Reviews; 2010.
    1. Eroğlu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taşkin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacenta/early postpartum period with interval period: 1 year follow-up. Contraception. 2006;74(5):376–381. doi: 10.1016/j.contraception.2006.07.003.
    1. Arrowsmith ME, Aicken CR, Saxena S, Majeed A. Strategies for improving the acceptability and acceptance of the copper intrauterine device. Cochrane Database Syst Rev. 2012;(3):1-40. Art. No.: CD008896.
    1. Bryant AG, Kamanga G, Stuart GS, Haddad LB, Meguid T, Mhango C. Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial. Afr J Reprod Health. 2013;17(2):72–79.
    1. Mohamed SA, Kamel MA, Shaaban OM, Salem HT. Acceptability for the use of postpartum intrauterine contraceptive devices: assiut experience. Med Prininciples Pract. 2003;12:170–175. doi: 10.1159/000070754.
    1. McKaig C, Blanchard H. The IUD: A contraceptive option for postpartum and postabortion women. 2006.
    1. Van Kets H, Kleinhout J, Osler M, Parewijck W, Zighelboim I, Tatum HJ. Clinical experience with the Gyne-T 380 postpartum intrauterine device. Fertil Steril. 1991;55(6):1144–1149. doi: 10.1016/S0015-0282(16)54366-0.
    1. Tatum HJ, Beltran RS, Ramos R, Van Kets H, Sivin I, Schmidt FH. Immediate postplacental insertion of GYNE-T 380 and GYNE-T 380 Postpartum intrauterine contraceptive devices: Randomized study. Obstet Gynecol. 1996;175(5):1231–1235.
    1. Hussey MA, Hughes JP. Design and analysis of the stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–191. doi: 10.1016/j.cct.2006.05.007.
    1. Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, Azad K, Costello A, Osrin D. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011;12:151. doi: 10.1186/1745-6215-12-151.
    1. Ali MM, Sadler RK, Cleland J, Ngo TD, Shah IH. Long-term contraceptive protection, discontinuation and switching behaviour: intrauterine device (IUD) use dynamics in 14 developing countries. 2011.
    1. Family Health Bureau Minstry of Health, Sri Lanka. Annual Report on Family Health 2012. 2012
    1. Ministry of Health and Population (MOHP) Nepal Demographic and Health Survey 2011. Nepal: New ERA, ICF International Inc; 2012.
    1. Govindarajulu US, Spiegelman D, Thurston SW, Ganguli B, Eisen EA. Comparing smoothing techniques in Cox models for exposure–response relationships. Stat Med. 2007;26(20):3735–3752. doi: 10.1002/sim.2848.
    1. Hernan MA, Brumback B, Robins JM. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology. 2000;11(5):561–570. doi: 10.1097/00001648-200009000-00012.
    1. Rotnitzky A, Robins JM. Semiparametric regression estimation in the presence of dependent censoring. Biometrika. 1995;82(4):805–820. doi: 10.1093/biomet/82.4.805.
    1. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177–188. doi: 10.1016/0197-2456(86)90046-2.
    1. Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539–1558. doi: 10.1002/sim.1186.
    1. Takkouche B, Cadarso-Suarez C, Spiegelman D. Evaluation of old and new tests of heterogeneity in epidemiologic meta-analysis. Am J Epidemiol. 1999;150(2):206–215. doi: 10.1093/oxfordjournals.aje.a009981.

Source: PubMed

3
Tilaa