NCT05079100

Brief Summary

Family planning (FP) is the most supported, reasonable public health service to prevent both maternal and newborn mortality and decrease the risk of adverse maternal, perinatal, and infant outcomes. The World Health Organization's (WHO) recommend of waiting at least 2 years after a live birth before attempting the next pregnancy as short interval between pregnancies increase risk of preterm labor; low birth weight; fetal, early neonatal and infant death; and serious maternal outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

28 days

First QC Date

September 14, 2021

Last Update Submit

January 22, 2024

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (1)

  • number of participant will Use postpartum contraception methods

    we will study by questionnaire in interview session the number of participants who will use postpartum contraception methods within 6 weeks postpartum

    6 weeks

Study Arms (2)

group of intervention (counseling)

ACTIVE COMPARATOR

the group will receive the contraception counseling

Other: postpartum contraception method counselling

group of control (no counseling)

NO INTERVENTION

this group will not receive any counseling

Interventions

postpartum contraception method counsellingOTHER

It will be face-to-face counseling with females about the use of postpartum contraception methods within 6 weeks postpartum.

group of intervention (counseling)

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women who delivered in Women's Health hospitals, Assiut university hospitals.
  • Women in reproductive age (15 - 49 years).
  • Accepting to share in our study.

You may not qualify if:

  • Women diagnosed with mental problems or postpartum psychosis
  • Women with unstable hemodynamic status.
  • Women after Peripartum hysterectomy or tubal ligation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (6)

  • Gul X, Hameed W, Hussain S, Sheikh I, Siddiqui JU. A study protocol for an mHealth, multi-centre randomized control trial to promote use of postpartum contraception amongst rural women in Punjab, Pakistan. BMC Pregnancy Childbirth. 2019 Aug 8;19(1):283. doi: 10.1186/s12884-019-2427-z.

    PMID: 31395034BACKGROUND

  • Cooper CM, Charurat E, El-Adawi I, Kim YM, Emerson MR, Zaki W, Schuster A. Postpartum Family Planning During Sociopolitical Transition: Findings from an Integrated Community-Based Program in Egypt. Int Perspect Sex Reprod Health. 2016 Jun 1;42(2):57-69. doi: 10.1363/42e1216.

    PMID: 28825907BACKGROUND

  • Pradhan E, Canning D, Shah IH, Puri M, Pearson E, Thapa K, Bajracharya L, Maharjan M, Maharjan DC, Bajracharya L, Shakya G, Chaudhary P. Integrating postpartum contraceptive counseling and IUD insertion services into maternity care in Nepal: results from stepped-wedge randomized controlled trial. Reprod Health. 2019 May 29;16(1):69. doi: 10.1186/s12978-019-0738-1.

    PMID: 31142344BACKGROUND

  • Burapasikarin C, Manonai J, Wattanayingcharoenchai R. The effect of an educational video on long-acting reversible contraception (LARC) utilization at 6-8 weeks postpartum period: a randomized controlled trial. Arch Gynecol Obstet. 2020 Dec;302(6):1503-1509. doi: 10.1007/s00404-020-05710-3. Epub 2020 Jul 30.

    PMID: 32734413BACKGROUND

  • Tang JH, Dominik RC, Zerden ML, Verbiest SB, Brody SC, Stuart GS. Effect of an educational script on postpartum contraceptive use: a randomized controlled trial. Contraception. 2014 Aug;90(2):162-7. doi: 10.1016/j.contraception.2014.03.017. Epub 2014 Apr 12.

    PMID: 24833047BACKGROUND

  • Harrington EK, Drake AL, Matemo D, Ronen K, Osoti AO, John-Stewart G, Kinuthia J, Unger JA. An mHealth SMS intervention on Postpartum Contraceptive Use Among Women and Couples in Kenya: A Randomized Controlled Trial. Am J Public Health. 2019 Jun;109(6):934-941. doi: 10.2105/AJPH.2019.305051.

    PMID: 31067089BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Dalia Galal Mahran, Prof

    Department of public health and community medicine, Faculty of medicine, Assiut university.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 15, 2021

Study Start

February 1, 2022

Primary Completion

March 1, 2022

Study Completion

May 20, 2022

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

EG(1)