Skip to main content
OpenTrials
Completed

NCT Number: NCT02718222

Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Research on Enviornment Health and Population Activities, Kathmandu, Nepal

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post-partum IUD

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • International Federation of Gynaecology and Obstetrics

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2016
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.