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Published in: BMC Pregnancy and Childbirth 1/2016

Open Access 01-12-2016 | Study protocol

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

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

Published in: BMC Pregnancy and Childbirth | Issue 1/2016

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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.
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Literature
1.
go back to reference Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80:327–36.CrossRefPubMed Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80:327–36.CrossRefPubMed
2.
go back to reference Rossier C, Bradley SEK, Ross J, Winfrey W. Reassessing Unmet Need for Family Planning in the Postpartum Period. Stud Fam Plann. 2015;46(4):355–67.CrossRefPubMed Rossier C, Bradley SEK, Ross J, Winfrey W. Reassessing Unmet Need for Family Planning in the Postpartum Period. Stud Fam Plann. 2015;46(4):355–67.CrossRefPubMed
3.
go back to reference Winfrey W, Kshitiz R. Use of Family Planning in Postpartum Period. 2014, 36. Winfrey W, Kshitiz R. Use of Family Planning in Postpartum Period. 2014, 36.
4.
go back to reference World Health Organization (WHO). Medical Eligibility Criteria for Contraceptive use: Fourth Edition, 2009. 2010. World Health Organization (WHO). Medical Eligibility Criteria for Contraceptive use: Fourth Edition, 2009. 2010.
5.
go back to reference Grimes DA, Lopez LM, Schulz KF. Van Vilet HAAM. Stanwood NL: Immediate post-partum insertion of intrauterine devices. Cochrane Database of Systematic Reviews; 2010 (5). Grimes DA, Lopez LM, Schulz KF. Van Vilet HAAM. Stanwood NL: Immediate post-partum insertion of intrauterine devices. Cochrane Database of Systematic Reviews; 2010 (5).
6.
go back to reference 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):376–81.CrossRefPubMed 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):376–81.CrossRefPubMed
7.
go back to reference 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. 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.
8.
go back to reference 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):72–9.PubMed 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):72–9.PubMed
9.
go back to reference Mohamed SA, Kamel MA, Shaaban OM, Salem HT. Acceptability for the use of postpartum intrauterine contraceptive devices: assiut experience. Med Prininciples Pract. 2003;12:170–5.CrossRef Mohamed SA, Kamel MA, Shaaban OM, Salem HT. Acceptability for the use of postpartum intrauterine contraceptive devices: assiut experience. Med Prininciples Pract. 2003;12:170–5.CrossRef
10.
go back to reference McKaig C, Blanchard H. The IUD: A contraceptive option for postpartum and postabortion women. 2006. McKaig C, Blanchard H. The IUD: A contraceptive option for postpartum and postabortion women. 2006.
11.
go back to reference 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):1144–9.CrossRefPubMed 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):1144–9.CrossRefPubMed
12.
go back to reference 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):1231–5. 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):1231–5.
13.
go back to reference Hussey MA, Hughes JP. Design and analysis of the stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91.CrossRefPubMed Hussey MA, Hughes JP. Design and analysis of the stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91.CrossRefPubMed
14.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
15.
go back to reference 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. 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.
16.
go back to reference Family Health Bureau Minstry of Health, Sri Lanka. Annual Report on Family Health 2012. 2012 Family Health Bureau Minstry of Health, Sri Lanka. Annual Report on Family Health 2012. 2012
17.
go back to reference Ministry of Health and Population (MOHP). Nepal Demographic and Health Survey 2011. Nepal: New ERA, ICF International Inc; 2012. Ministry of Health and Population (MOHP). Nepal Demographic and Health Survey 2011. Nepal: New ERA, ICF International Inc; 2012.
18.
go back to reference 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):3735–52.CrossRefPubMed 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):3735–52.CrossRefPubMed
19.
go back to reference 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):561–70.CrossRefPubMed 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):561–70.CrossRefPubMed
20.
go back to reference Rotnitzky A, Robins JM. Semiparametric regression estimation in the presence of dependent censoring. Biometrika. 1995;82(4):805–20.CrossRef Rotnitzky A, Robins JM. Semiparametric regression estimation in the presence of dependent censoring. Biometrika. 1995;82(4):805–20.CrossRef
21.
22.
go back to reference Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539–58.CrossRefPubMed Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539–58.CrossRefPubMed
23.
go back to reference 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):206–15.CrossRefPubMed 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):206–15.CrossRefPubMed
Metadata
Title
Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster-randomized stepped-wedge trial
Authors
David Canning
Iqbal H. Shah
Erin Pearson
Elina Pradhan
Mahesh Karra
Leigh Senderowicz
Till Bärnighausen
Donna Spiegelman
Ana Langer
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2016
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-016-1160-0

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