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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 Counseling and Delivery Room Services in Nepal, Sri Lanka, Tanzania

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02718222
Enrollment
140258
Registered
2016-03-24
Start date
2015-09-30
Completion date
2018-12-31
Last updated
2019-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Post-partum intrauterine device (PPIUD)

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.

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.

Interventions

DEVICEPost-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.

Sponsors

International Federation of Gynaecology and Obstetrics
CollaboratorOTHER
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage uptake of PPIUDWithin 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

MeasureTime frameDescription
Percentage of women receiving PPIUD counselingWithin 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.
Percentage of PPIUD acceptors who have expulsions at 4-6 weeks postpartum6 weeks postpartumParticipants 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.
Percentage of women using modern contraception at 9 months postpartum9 months postpartumParticipants will be interviewed at 9 months and asked whether they are using a modern method of contraception.
Percentage of women using modern contraception at 18 months postpartum18 months postpartumParticipants will be interviewed at 18 months and asked whether they are using a modern method of contraception.
Percentage of women pregnant at 18 months postpartum18 months postpartumParticipants will be interviewed at 18 months and asked whether they are pregnant.

Countries

Nepal, Sri Lanka, Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026