Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

August 6, 2019 updated by: Iqbal Shah, Harvard School of Public Health (HSPH)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • PPIUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within approximately 24 hours postpartum, before discharge from the hospital.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within approximately 24 hours postpartum, before discharge from the hospital.
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.
6 weeks postpartum
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.
9 months postpartum
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.
18 months postpartum
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.
18 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

International Federation of Gynaecology and Obstetrics

Investigators

  • Principal Investigator: Iqbal H Shah, PhD, Harvard School of Public Health (HSPH)
  • Principal Investigator: David Canning, PhD, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6904190-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Investigators intend to make a de-identified dataset available after conclusion of the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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