Testing a Modified Family Planning Intervention for Postp... | NCT04068870

Studies
Testing a Modified Family Planning Intervention for Postpartum Women in Uganda

NCT04068870

Sponsor

University of Vermont

Status

Unknown status

Last Update Posted

Aug 28, 2019Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Contraceptive Usage

Interventions

Contraceptive management program

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2019Actual

Primary Completion Date

Apr 2020Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Aug 22, 2019

First Submission Date that Met QC Criteria

Aug 22, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2019

Last Update Posted Date

Aug 28, 2019Actual

Name	Class
African Community Center for Social Sustainability	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test whether offering incentives to encourage women to attend one-on-one family planning education sessions and offering free, onsite prescription contraceptive methods increases use and continuation of prescription contraception among postpartum women in Uganda. This intervention is modified from one that has been effective outside of Uganda.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Contraceptive management program	Experimental		Behavioral: Contraceptive management program
Usual care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Contraceptive management program	Behavioral	The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) incentivized visits.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Period prevalence use of a prescription contraceptive	Period prevalence use of a prescription contraceptive	6 months after delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-45 years of age
Not planning on getting pregnant in the next 4 months
Less than 3 months postpartum
No history of tubal ligation or hysterectomy
No recent prescription contraceptive use (no pill, intrauterine device or implant use in the past 7 days or injection use in the past 3 months)
Medically eligible to use prescription contraceptives
Bringing baby to immunization clinic for the first time

Exclusion Criteria:

Failure to meet the aforementioned inclusion criteria

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Heil, PhD	Contact	802-656-8712		sarah.heil@uvm.edu

Overall Officials

Name	Affiliation	Role
Sarah Heil, PhD	University of Vermont	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nakaseke District Hospital	Recruiting	Nakaseke			Uganda

Condition Browse Module

MeSH Terms

ID	Term
D003268	Contraception Behavior

Ancestor Terms

ID	Term
D043762	Reproductive Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided