Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

Contraception Clinical Trial

Official title:

Studying the Impact and Performance of Institutionalizing Immediate Post-partum IUD Services as a Routine Part of Antenatal Counseling and Delivery Room Services in Nepal, Sri Lanka, Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718222
• Other study ID #: 6904190-01
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.

Description:

The International Federation of Gynaecology and Obstetrics (FIGO) has designed and is planning to implement, through its nationally-affiliated Associations of Gynaecologists and Obstetricians, an intervention program on post-partum IUD (PPIUD) services. As part of this Program, FIGO is responsible for information material, training providers, improving facilities, quality of service, and monitoring the program. Independent of the implementation, this study will measure the impact and performance of this intervention in three (Sri Lanka, Nepal and Tanzania) of the six countries participating in the FIGO project entitled: "Institutionalization of immediate post-partum IUD (PPIUD) services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Kenya, India, Tanzania, Nepal and Bangladesh." The FIGO intervention will take place over a nine-month period in Tanzania (nine months in the first group of three hospitals and three months in the second group of three hospitals), and over a fifteen-month period in Nepal and Sri Lanka (fifteen months in the first group of three hospitals and nine months in the second group of three hospitals). Investigators will study both the impact of the intervention on the uptake and subsequent continued use of PPIUD and the extent to which the intervention leads to the institutionalization of postpartum IUD services in the hospitals during and after the FIGO intervention and to what extent the service diffuses to other hospitals or providers. The institutionalization and diffusion of the intervention will be measured by interviewing and following up trained providers, review of hospital records and baseline, during intervention and post-intervention facility surveys.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140258
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Delivered in intervention hospital during 12-month enrollment period (Tanzania)/18-month enrollment period (Nepal and Sri Lanka)

Exclusion Criteria:

• Does not live in the country where delivered

• Tanzania only: Under age 18

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Nepal	Center for Research on Enviornment Health and Population Activities	Kathmandu
Sri Lanka	Sri Lanka College of Obstetricians and Gynecologists	Colombo
Tanzania	Management and Development for Health	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	International Federation of Gynaecology and Obstetrics

Countries where clinical trial is conducted

Nepal,  Sri Lanka,  Tanzania, 

References & Publications (21)

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.

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;(3):CD008896. doi: 10.1002/14651858.CD008896.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Sep 15. — View Citation

Family Health Bureau MoH, Sri Lanka. Annual Report on Family Health 2012. Colombo, Sri Lanka: Ministry of Health, Sri Lanka, 2012.

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2014;7:CD001777. — View Citation

Hernán 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. — View Citation

Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. Epub 2006 Jul 7. Review. — View Citation

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. Review. — View Citation

McKaig, Catherine and Blanchard, Holly. The IUD: A contraceptive option for postpartum and postabortion women. Access/USAID.

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.

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. — View Citation

Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63. — View Citation

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. — View Citation

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.

World Health Organization. Medical Eligibility Criteria for Contraceptive use: Fourth Edition, 2009. 2010. Geneva: World Health Organization.

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage uptake of PPIUD	To ascertain what percentage of women delivering in study hospitals take uptake PPIUD, participants will be interviewed after delivery, before they are discharged from the hospital.	Within approximately 24 hours postpartum, before discharge from the hospital.
Secondary	Percentage of women receiving PPIUD counseling	To ascertain what percentage of women delivering in study hospitals receive counseling on PPIUD, participants will be interviewed after delivery, before they are discharged from the hospital.	Within approximately 24 hours postpartum, before discharge from the hospital.
Secondary	Percentage of PPIUD acceptors who have expulsions at 4-6 weeks postpartum	Participants who have not deliberately removed the PPIUD will be examined by providers at 4-6 weeks postpartum, and providers will report whether the PPIUD was expelled.	6 weeks postpartum
Secondary	Percentage of women using modern contraception at 9 months postpartum	Participants will be interviewed at 9 months and asked whether they are using a modern method of contraception.	9 months postpartum
Secondary	Percentage of women using modern contraception at 18 months postpartum	Participants will be interviewed at 18 months and asked whether they are using a modern method of contraception.	18 months postpartum
Secondary	Percentage of women pregnant at 18 months postpartum	Participants will be interviewed at 18 months and asked whether they are pregnant.	18 months postpartum