Contraceptive UsageNCT05079100
Effectiveness of Counseling on Use of Postpartum Family Planning.
A study testing postpartum contraception method counselling in people with Contraceptive Usage, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- postpartum contraception method counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women who delivered in Women's Health hospitals, Assiut university hospitals.
- Women in reproductive age (15 - 49 years).
- Accepting to share in our study.
Who cannot join
- Women diagnosed with mental problems or postpartum psychosis
- Women with unstable hemodynamic status.
- Women after Peripartum hysterectomy or tubal ligation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraceptive Usage
- Being tested
- postpartum contraception method counselling
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postpartum contraception method counsellingOther
It will be face-to-face counseling with females about the use of postpartum contraception methods within 6 weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| group of intervention (counseling) | Active comparator | the group will receive the contraception counseling Receives: Other: postpartum contraception method counselling |
| group of control (no counseling) | No intervention | this group will not receive any counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Feb 2022
- Primary completion1 Mar 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Ismail Mohamed, Assiut University
- Investigators
- Dalia Galal Mahran, Prof, Study director, Department of public health and community medicine, Faculty of medicine, Assiut university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079100
- Sponsor's protocol ID
- ECAUPFP
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31395034Cooper 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.
PubMed 28825907Pradhan 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.
PubMed 31142344Burapasikarin 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.
PubMed 32734413Tang 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.
PubMed 24833047Harrington 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.
PubMed 31067089
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Counseling on Attitude and Use of Postpartum Family Planning Within 6 Weeks.
- ClinicalTrials.gov ID
- NCT05079100
- Acronym / sponsor ID
- ECAUPFP
- Conditions
- Contraceptive Usage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group of intervention (counseling) | Active comparator | Other: postpartum contraception method counsellingthe group will receive the contraception counseling |
| group of control (no counseling) | No intervention | –this group will not receive any counseling |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women who delivered in Women's Health hospitals, Assiut university hospitals.
- Women in reproductive age (15 - 49 years).
- Accepting to share in our study.
Key exclusion criteria (3 listed)
- Women diagnosed with mental problems or postpartum psychosis
- Women with unstable hemodynamic status.
- Women after Peripartum hysterectomy or tubal ligation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postpartum contraception method counsellingIt will be face-to-face counseling with females about the use of postpartum contraception methods within 6 weeks postpartum. | Other | group of intervention (counseling) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 31395034Gul 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.
- Background: PubMed 28825907Cooper 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.
- Background: PubMed 31142344Pradhan 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.
- Background: PubMed 32734413Burapasikarin 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.
- Background: PubMed 24833047Tang 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.
- Background: PubMed 31067089Harrington 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.
- Individual participant dataSharing planned: Undecided
Related trials for Contraceptive Usage
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Enrolling by invitation
A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Contraceptive Usage, Contraceptive Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Galal Mahran, Prof study director
Department of public health and community medicine, Faculty of medicine, Assiut university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postpartum contraception method counselling in people with Contraceptive Usage, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participant will Use postpartum contraception methods (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079100, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.