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Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

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ClinicalTrials.gov Identifier: NCT02718222
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
International Federation of Gynaecology and Obstetrics
Information provided by (Responsible Party):
Iqbal Shah, Harvard School of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
Contraception Device: Post-partum IUD Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140258 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: 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.

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.
Other Name: PPIUD

Experimental: 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.

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.
Other Name: PPIUD




Primary Outcome Measures :
  1. Percentage uptake of PPIUD [ Time Frame: Within approximately 24 hours postpartum, before discharge from the hospital. ]
    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.


Secondary Outcome Measures :
  1. Percentage of women receiving PPIUD counseling [ Time Frame: Within approximately 24 hours postpartum, before discharge from the hospital. ]
    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.

  2. Percentage of PPIUD acceptors who have expulsions at 4-6 weeks postpartum [ Time Frame: 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.

  3. Percentage of women using modern contraception at 9 months postpartum [ Time Frame: 9 months postpartum ]
    Participants will be interviewed at 9 months and asked whether they are using a modern method of contraception.

  4. Percentage of women using modern contraception at 18 months postpartum [ Time Frame: 18 months postpartum ]
    Participants will be interviewed at 18 months and asked whether they are using a modern method of contraception.

  5. Percentage of women pregnant at 18 months postpartum [ Time Frame: 18 months postpartum ]
    Participants will be interviewed at 18 months and asked whether they are pregnant.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718222


Locations
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Nepal
Center for Research on Enviornment Health and Population Activities
Kathmandu, Nepal
Sri Lanka
Sri Lanka College of Obstetricians and Gynecologists
Colombo, Sri Lanka
Tanzania
Management and Development for Health
Dar es Salaam, Tanzania
Sponsors and Collaborators
Harvard School of Public Health
International Federation of Gynaecology and Obstetrics
Investigators
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Principal Investigator: Iqbal H Shah, PhD Harvard School of Public Health
Principal Investigator: David Canning, PhD Harvard School of Public Health
Publications:
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.
McKaig, Catherine and Blanchard, Holly. The IUD: A contraceptive option for postpartum and postabortion women. Access/USAID.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Iqbal Shah, Principal Research Scientist, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02718222    
Other Study ID Numbers: 6904190-01
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators intend to make a de-identified dataset available after conclusion of the study.
Keywords provided by Iqbal Shah, Harvard School of Public Health:
Post-partum intrauterine device (PPIUD)