Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

NCT02718222 | Completed DMC

• 1 other identifier: 6904190-01
• Study Type: interventional
• Target: 140,258
• Locations: 3 countries
• Sites: 3

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.

Conditions

Contraception

Keywords

Post-partum intrauterine device (PPIUD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of women receiving PPIUD counseling

  Within approximately 24 hours postpartum, before discharge from the hospital.

• Percentage of PPIUD acceptors who have expulsions at 4-6 weeks postpartum

  6 weeks postpartum

• Percentage of women using modern contraception at 9 months postpartum

  9 months postpartum

• Percentage of women using modern contraception at 18 months postpartum

  18 months postpartum

• Percentage of women pregnant at 18 months postpartum

  18 months postpartum

Study Arms (2)

3-9 months PPIUD intervention

EXPERIMENTAL

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

9-15 months PPIUD intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: PPIUD

3-9 months PPIUD intervention; 9-15 months PPIUD intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Does not live in the country where delivered
• Tanzania only: Under age 18

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• International Federation of Gynaecology and Obstetrics: collaborator

Study Sites (3)

Center for Research on Enviornment Health and Population Activities

Kathmandu, Nepal

Location

Sri Lanka College of Obstetricians and Gynecologists

Colombo, Sri Lanka

Location

Management and Development for Health

Dar es Salaam, Tanzania

Location

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Study Officials

• Iqbal H Shah, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• David Canning, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 24, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

TA (1); NE (1); SR (1)