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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05079100
Other study ID # ECAUPFP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date May 20, 2022

Study information

Verified date January 2024
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 20, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 49 Years
Eligibility Inclusion Criteria: 1. Women who delivered in Women's Health hospitals, Assiut university hospitals. 2. Women in reproductive age (15 - 49 years). 3. Accepting to share in our study. Exclusion Criteria: 1. Women diagnosed with mental problems or postpartum psychosis 2. Women with unstable hemodynamic status. 3. Women after Peripartum hysterectomy or tubal ligation.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Assiut University Assuit Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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