- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05079100
Effectiveness of Counseling on Use of Postpartum Family Planning.
January 22, 2024 updated by: Yasmin Ismail Mohamed, Assiut University
Effectiveness of Counseling on Attitude and Use of Postpartum Family Planning Within 6 Weeks.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
So WHO recommends postpartum family planning (PPFP) for healthy birth spacing.
PPFP is divided into three stages immediate: within 48 hours following delivery, early: within the first 6 weeks after delivery, late: within 12 months postpartum.
Fertility can return as soon as 45 days after delivery for non-breastfeeding women, and among women who are not breastfeeding exclusively, fertility can return before the return of menses.
Providing PPFP instantaneously following delivery may be likeable for women who prefer effective postpartum protection as the return of fertility may be hard to expect.
So Promoting PPFP use was documented in different communities, interventions included conversational, SMS, brochure and video-based contraceptive education in antenatal or postnatal visits.
However, the unmet need for FP is high in the postpartum period, ranging from 32 to 62% in low and middle-income countries depending on the definition used.
that is why WHO recommends that all women should be offered counselling within 6 weeks postpartum so we will study the impact of post-partum counselling pre and post-discharge on intent and use of a reliable family planning method.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Assiut
-
Assuit, Assiut, Egypt, 71515
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women who delivered in Women's Health hospitals, Assiut university hospitals.
- Women in reproductive age (15 - 49 years).
- Accepting to share in our study.
Exclusion Criteria:
- Women diagnosed with mental problems or postpartum psychosis
- Women with unstable hemodynamic status.
- Women after Peripartum hysterectomy or tubal ligation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group of intervention (counseling)
the group will receive the contraception counseling
|
It will be face-to-face counseling with females about the use of postpartum contraception methods within 6 weeks postpartum.
|
|
No Intervention: group of control (no counseling)
this group will not receive any counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of participant will Use postpartum contraception methods
Time Frame: 6 weeks
|
we will study by questionnaire in interview session the number of participants who will use postpartum contraception methods within 6 weeks postpartum
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dalia Galal Mahran, Prof, Department of public health and community medicine, Faculty of medicine, Assiut university.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
May 20, 2022
Study Registration Dates
First Submitted
September 14, 2021
First Submitted That Met QC Criteria
October 2, 2021
First Posted (Actual)
October 15, 2021
Study Record Updates
Last Update Posted (Estimated)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ECAUPFP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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