Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Device: Post-partum IUD


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-9 months PPIUD intervention<br>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<br>* 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.<br>* Other names: PPIUD;|
| Experimental: 9-15 months PPIUD intervention<br>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<br>* 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.<br>* Other names: PPIUD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of women pregnant at 18 months postpartum | Participants will be interviewed at 18 months and asked whether they are pregnant. | 18 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-partum intrauterine device (PPIUD)