Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
NCT ID: NCT02718222
Last Updated: 2019-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140258 participants
INTERVENTIONAL
2015-09-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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3-9 months PPIUD intervention
Tanzania: Baseline (no intervention) period is 9 months. Post-partum IUD intervention begins after 9 months and continues for 3 months.
Nepal and Sri Lanka: Baseline (no intervention) period is 9 months. Post-partum IUD intervention begins after 9 months and continues for 9 months.
Post-partum IUD
The PPIUD intervention aims to address the postpartum contraceptive needs of women by training community midwives, health workers, doctors and delivery unit staff in postpartum IUD counselling and insertion.
9-15 months PPIUD intervention
Tanzania: Baseline (no intervention) period is 3 months. Post-partum IUD intervention begins after 3 months and continues for 9 months.
Nepal and Sri Lanka: Baseline (no intervention) period is 3 months. Post-partum IUD intervention begins after 3 months and continues for 15 months.
Post-partum IUD
The PPIUD intervention aims to address the postpartum contraceptive needs of women by training community midwives, health workers, doctors and delivery unit staff in postpartum IUD counselling and insertion.
Interventions
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Post-partum IUD
The PPIUD intervention aims to address the postpartum contraceptive needs of women by training community midwives, health workers, doctors and delivery unit staff in postpartum IUD counselling and insertion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Tanzania only: Under age 18
FEMALE
Yes
Sponsors
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International Federation of Gynaecology and Obstetrics
OTHER
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Iqbal Shah
Principal Research Scientist
Principal Investigators
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Iqbal H Shah, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
David Canning, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Center for Research on Enviornment Health and Population Activities
Kathmandu, , Nepal
Sri Lanka College of Obstetricians and Gynecologists
Colombo, , Sri Lanka
Management and Development for Health
Dar es Salaam, , Tanzania
Countries
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References
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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 Sep;11(5):561-70. doi: 10.1097/00001648-200009000-00012.
Gong Q, Schaubel DE. Partly conditional estimation of the effect of a time-dependent factor in the presence of dependent censoring. Biometrics. 2013 Jun;69(2):338-47. doi: 10.1111/biom.12023. Epub 2013 May 2.
Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.
Govindarajulu US, Spiegelman D, Thurston SW, Ganguli B, Eisen EA. Comparing smoothing techniques in Cox models for exposure-response relationships. Stat Med. 2007 Sep 10;26(20):3735-52. doi: 10.1002/sim.2848.
Ross John A. and Winfrey William L. Contraceptive use, intention to use and unmet need during the extended postpartum period. International Family Planning Perspectives, 2001, 27(1): 20-27.
Rotnitzky A, Robins JM. Semiparametric regression estimation in the presence of dependent censoring. Biometrika. 1995 Dec;82(4):805-20.
Winfrey, William and Rakesh Kshitiz. Use of Family Planning in Postpartum Period. DHS Comparative Report No. 36. 2014. Rockville, Maryland, USA: ICF International.
Medical Eligibility Criteria for Contraceptive Use: A WHO Family Planning Cornerstone. 4th edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138639/
Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.
Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009 Oct;80(4):327-36. doi: 10.1016/j.contraception.2009.03.024. Epub 2009 Aug 29.
Grimes DA, Lopez LM, Schulz KF, Stanwood NL. Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001777. doi: 10.1002/14651858.CD001777.pub3.
McKaig, Catherine and Blanchard, Holly. The IUD: A contraceptive option for postpartum and postabortion women. Access/USAID.
Mohamed SA, Kamel MA, Shaaban OM, Salem HT. Acceptability for the use of postpartum intrauterine contraceptive devices: Assiut experience. Med Princ Pract. 2003 Jul-Sep;12(3):170-5. doi: 10.1159/000070754.
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 Jun;17(2):72-9.
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 Mar 14;2012(3):CD008896. doi: 10.1002/14651858.CD008896.pub2.
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
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 Jun 14;12:151. doi: 10.1186/1745-6215-12-151.
Ali MMS, Rachael K, Cleland John, Ngo Thoai D, and Shah Iqbal H. Long-term contraceptive protection, discontinuation and switching behaviour: intrauterine device (IUD) use dynamics in 14 developing countries. London: World Health Organization and Marie Stopes International, 2011.
Family Health Bureau MoH, Sri Lanka. Annual Report on Family Health 2012. Colombo, Sri Lanka: Ministry of Health, Sri Lanka, 2012.
Ministry of Health and Population (MOHP) [Nepal], New ERA, and ICF International Inc. Nepal Demographic and Health Survey 2011. Kathmandu, Nepal: Ministry of Health and Population, New ERA, and ICF International, Calverton, Maryland, 2012.
Pearson E, Senderowicz L, Pradhan E, Francis J, Muganyizi P, Shah I, Canning D, Karra M, Ulenga N, Barnighausen T. Effect of a postpartum family planning intervention on postpartum intrauterine device counseling and choice: evidence from a cluster-randomized trial in Tanzania. BMC Womens Health. 2020 May 12;20(1):102. doi: 10.1186/s12905-020-00956-0.
Karra M, Pearson E, Pradhan E, de Silva R, Samarasekera A, Canning D, Shah I, Weerasekera D, Senanayake H. The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka. Trials. 2019 Jul 8;20(1):407. doi: 10.1186/s13063-019-3473-6.
Pradhan E, Canning D, Shah IH, Puri M, Pearson E, Thapa K, Bajracharya L, Maharjan M, Maharjan DC, Bajracharya L, Shakya G, Chaudhary P. Integrating postpartum contraceptive counseling and IUD insertion services into maternity care in Nepal: results from stepped-wedge randomized controlled trial. Reprod Health. 2019 May 29;16(1):69. doi: 10.1186/s12978-019-0738-1.
Pradhan E, Pearson E, Puri M, Maharjan M, Maharjan DC, Shah I. Determinants of imbalanced sex ratio at birth in Nepal: evidence from secondary analysis of a large hospital-based study and nationally-representative survey data. BMJ Open. 2019 Jan 30;9(1):e023021. doi: 10.1136/bmjopen-2018-023021.
Canning D, Shah IH, Pearson E, Pradhan E, Karra M, Senderowicz L, Barnighausen T, Spiegelman D, Langer A. Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster-randomized stepped-wedge trial. BMC Pregnancy Childbirth. 2016 Nov 21;16(1):362. doi: 10.1186/s12884-016-1160-0.
Other Identifiers
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6904190-01
Identifier Type: -
Identifier Source: org_study_id
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