NCT06965283

Brief Summary

This study aims to explore the effectiveness of integrated package interventions within maternal and child health services in improving modern postpartum contraceptive use in northeast Ethiopia. Its primary objective is to enhance the utilization of postpartum contraceptive methods to reduce unmet needs for these methods in the Amhara region of Ethiopia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
607

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 11, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

Modern contraceptive usePostpartum family planningService integrationMaternal & child health services

Outcome Measures

Primary Outcomes (1)

  • Modern postpartum contraceptive use

    The primary outcome measure is modern postpartum contraceptive use, assessed via interviewer-administered questionnaires. Data were collected using standardized, pre-tested tools by trained midwives with prior data collection experience. Quantitative data will be analyzed using STATA 17 software with a Generalized Estimating Equation (GEE) model. The outcome variable was evaluated by measuring the effectiveness of the intervention package, which was delivered by trained healthcare providers across selected maternal and child health (MCH) units. These units included labor/delivery, immunization, postnatal care (PNC), PMTCT (Prevention of Mother-to-Child Transmission), and under-five child outpatient services. The study followed a pre/post-intervention design: a baseline assessment was conducted first, followed by a six-month intervention period, and a post-intervention assessment. The intervention's effect will be evaluated using difference-in-differences analysis.

    Up to six months

Study Arms (2)

This arm will be given the multiple behaviour change intervention

ACTIVE COMPARATOR

The intervention package includes: 1. PPFP refresher training for maternal and child health (MCH) providers across all MCH units (labor/delivery, postnatal care \[PNC\], immunization, PMTCT \[Prevention of Mother-to-Child Transmission\], and under-five childcare clinics). 2. Weekly mentoring (internal and external) led by senior gynecologists, obstetricians, and midwives at intervention hospitals. Mentoring sessions use anatomical models to address knowledge and skill gaps. MCH service coordinators also participate in training sessions to facilitate coaching and monitoring. 3. Standardized training modules based on guidelines developed by the Ethiopian Ministry of Health. 4. Monthly supportive supervision of PPFP services, conducted jointly by MCH unit coordinators and hospital management teams. This ensures early identification of bottlenecks and prompt resolution of challenges. 5. Monitoring of contraceptive methods and other materials availability

Behavioral: Providing training and Mentoring

The non intervention group were not given the intervention. Standard care will be continued

NO INTERVENTION

Usual care can be continued. No intervention can be given

Interventions

The intervention packages are providing postpartum family planning training at each MCH units, Using WHO PPFP counseling toolkit, mentoring health care provider to fill knowledge and skill gap, contraceptive logistic availability, and regular supportive supervision

This arm will be given the multiple behaviour change intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum mothers who gave birth one year preceding the survey
  • All postpartum mothers who come for maternal and child health services(PMTCT, PNC, labor, delivery, under 5 OPD care and immunization services and post-partum women units)

You may not qualify if:

  • Those participants who were seriously ill
  • Mentally unable to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dessie Comprehensive specialized Hospital

Dessie, Amhara, Ethiopia

Location

Dessie referral Hospital

Dessie, Amhara, Ethiopia

Location

Related Links

Study Officials

  • Gurmesa Tura Professor, PhD

    Jimma University

    STUDY DIRECTOR
  • Sisay Eshete Assistant professor, Msc

    Wollo University

    STUDY CHAIR
  • Getabalew Tsegaye Mr., Bsc

    Unaffilated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: All postpartum mothers who come to the hospital for labor/delivery, infant immunization, PMTCT (Prevention of Mother-to-Child Transmission), postnatal care (PNC), or under-five childcare services will be screened and counseled for postpartum family planning (PPFP). Those who decide to use a modern contraceptive method will either be referred to family planning units or provided with their chosen method directly. Postpartum mothers who do not initially decide to use a modern contraceptive method will receive additional counseling during their next visit. The intervention will be implemented by nurses and midwives working in selected maternal and child health units. These healthcare providers will receive a three-day PPFP training session delivered by a senior obstetrician-gynecologist, public health expert, and maternal/reproductive health specialist, all of whom are certified Training of Trainers. Coaching and mentoring will also be provided to ensure they acquire adequate knowledge.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 11, 2025

First Posted

May 11, 2025

Study Start

March 30, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

May 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

The result of this study will be published at reputable journal. So the data can be accessed in the published paper.

Locations