Clinical trial NCT02718222: Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Post-partum intrauterine device (PPIUD)
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: International Federation of Gynaecology and Obstetrics
First posted: 2016-03-24
Enrollment: 140258
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage uptake of PPIUD
timeFrame: Within approximately 24 hours postpartum, before discharge from the hospital.
Secondary outcomes:
measure: Percentage of women receiving PPIUD counseling
timeFrame: Within approximately 24 hours postpartum, before discharge from the hospital.
measure: Percentage of PPIUD acceptors who have expulsions at 4-6 weeks postpartum
timeFrame: 6 weeks postpartum
measure: Percentage of women using modern contraception at 9 months postpartum
timeFrame: 9 months postpartum
measure: Percentage of women using modern contraception at 18 months postpartum
timeFrame: 18 months postpartum
measure: Percentage of women pregnant at 18 months postpartum
timeFrame: 18 months postpartum
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Center for Research on Enviornment Health and Population Activities
city: Colombo
country: Sri Lanka
facility: Sri Lanka College of Obstetricians and Gynecologists
city: Dar es Salaam
country: Tanzania
facility: Management and Development for Health
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Iqbal H Shah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: David Canning, PhD
role: PRINCIPAL_INVESTIGATOR
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