ContraceptionNCT03890705
Postpartum Family Planning Utilization and Associated Factors Among Women During First Year After Childbirth in Assiut
An observational study of Contraception, run by Assiut University at 1 site in Egypt.
Trial summary
Postpartum family planning is defined as prevention of unintended pregnancy and closely spaced pregnancies during the first 12 months after the child birth postpartum contraceptive utilization is important because some women resume ovulation after 28 days postpartum inter-pregnancy intervals shorter than 18 to 24… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Contraception
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2019to Jun 2020
- Phase
- Observational
- 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
Study population: Women aged (15-49) who had given birth during the past 12 months and attending the Primary health care units for child immunization at the age of 12 months
Who may be able to join
- Women aged (15-49)
- and had given birth during the past 12 months.
Who cannot join
- Women that had children older than 12 months
- Pregnant women
- Sexually inactive women as widow and divorced
- Women who had done abdominal hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postpartum Family Planning Utilization and Associated Factors Among Women During the First Year After Childbirth in Assiut District
Postpartum family planning is defined as prevention of unintended pregnancy and closely spaced pregnancies during the first 12 months after the child birth postpartum contraceptive utilization is important because some women resume ovulation after 28 days postpartum inter-pregnancy intervals shorter than 18 to 24 months have been associated with an increased risk of fetal and maternal deaths ,35% of children younger than five deaths could be avoided if births spaced 36 months
Read the detailed description
According to Egyptian demographic health survey , unmet need for family planning increased from 11.6% in 2008 to be 12.6% in 2014, contraception prevalence rate decreased from 60% in 2008 to 59% in 2014.
In Assiut Contraception prevalence rate decreased form 47.4 in 2008 to 41.4 in 2014 Total fertility rate increased from 3 in 2008 to 3.5 children/woman in 2014, Assiut Total fertility rate was 4.2 children/woman in 2014 . projections for the year 2030 estimated that total fertility rate would decline to be 2.1 births/woman if Contraceptive prevalence rate could rise to be 74.4% .
Routine childhood immunization services include more than 500 million regular contacts annually, most women seek child immunization for their children so each immunization represents an opportunity to reach women with Postpartum family planning counselling so World Health Organization recommends Postpartum family planning as a critical healthcare component and World Contraception Day 26 September 2018, Met the theme"Postpartum family planning: essential for ensuring woman health and their babies" World Health Organization for family planning research agenda listed postpartum family planning utilization as a higher priority score with score 83.90
- Conditions
- Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| postpartum women | Women aged (15-49) and had given birth in the past 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum family planning utilization rate questionnaire
postpartum contraceptive utilization rate among women during first year postpartum in Assiut district
Measured: one year
Secondary outcomes (1)
factors affecting postpartum family planning utilization questionnaire
factors affecting postpartum family planning utilization among women who had given birth during the past 12 months in Assiut district
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Adel Zaky, Assiut University
- Investigators
- maria tadros, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890705
- Sponsor's protocol ID
- Family planning Assiut
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jackson E, Glasier A. Return of ovulation and menses in postpartum nonlactating women: a systematic review. Obstet Gynecol. 2011 Mar;117(3):657-662. doi: 10.1097/AOG.0b013e31820ce18c.
PubMed 21343770Ministry of Health and Population [Egypt], El-Zanaty and Associates [Egypt], and ICF International. 2015. Egypt Demographic and Health Survey 2014. Cairo, Egypt and Rockville, Maryland, USA: Ministry of Health and Population and ICF International.
El-Masry R et al. Unmet need for family planning among women in rural Egypt International Journal of Community Medicine and Public Health. 2018 Apr;5(4):1252-1261
Ali M, Seuc A, Rahimi A, Festin M, Temmerman M. A global research agenda for family planning: results of an exercise for setting research priorities. Bull World Health Organ. 2014 Feb 1;92(2):93-8. doi: 10.2471/BLT.13.122242. Epub 2013 Nov 4.
PubMed 24623902
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Family Planning Utilization and Associated Factors Among Women During the First Year After Childbirth in Assiut District
- ClinicalTrials.gov ID
- NCT03890705
- Acronym / sponsor ID
- Family planning Assiut
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 26 Mar 2019 (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.
Postpartum family planning is defined as prevention of unintended pregnancy and closely spaced pregnancies during the first 12 months after the child birth postpartum contraceptive utilization is important because some women resume ovulation after 28 days postpartum inter-pregnancy intervals shorter than 18 to 24 months have been associated with an increased risk of fetal and maternal deaths ,35% of children younger than five deaths could be avoided if births spaced 36 months
Detailed description
According to Egyptian demographic health survey , unmet need for family planning increased from 11.6% in 2008 to be 12.6% in 2014, contraception prevalence rate decreased from 60% in 2008 to 59% in 2014.
In Assiut Contraception prevalence rate decreased form 47.4 in 2008 to 41.4 in 2014 Total fertility rate increased from 3 in 2008 to 3.5 children/woman in 2014, Assiut Total fertility rate was 4.2 children/woman in 2014 . projections for the year 2030 estimated that total fertility rate would decline to be 2.1 births/woman if Contraceptive prevalence rate could rise to be 74.4% .
Routine childhood immunization services include more than 500 million regular contacts annually, most women seek child immunization for their children so each immunization represents an opportunity to reach women with Postpartum family planning counselling so World Health Organization recommends Postpartum family planning as a critical healthcare component and World Contraception Day 26 September 2018, Met the theme"Postpartum family planning: essential for ensuring woman health and their babies" World Health Organization for family planning research agenda listed postpartum family planning utilization as a higher priority score with score 83.90
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postpartum women | – | –Women aged (15-49) and had given birth in the past 12 months |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women aged (15-49) who had given birth during the past 12 months and attending the Primary health care units for child immunization at the age of 12 months
Key inclusion criteria (2 listed)
- Women aged (15-49)
- and had given birth during the past 12 months.
Key exclusion criteria (4 listed)
- Women that had children older than 12 months
- Pregnant women
- Sexually inactive women as widow and divorced
- Women who had done abdominal hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postpartum family planning utilization rate questionnaire
Time frame: one year
postpartum contraceptive utilization rate among women during first year postpartum in Assiut district
1 secondary outcome
factors affecting postpartum family planning utilization questionnaire
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 21343770Jackson E, Glasier A. Return of ovulation and menses in postpartum nonlactating women: a systematic review. Obstet Gynecol. 2011 Mar;117(3):657-662. doi: 10.1097/AOG.0b013e31820ce18c.
- BackgroundMinistry of Health and Population [Egypt], El-Zanaty and Associates [Egypt], and ICF International. 2015. Egypt Demographic and Health Survey 2014. Cairo, Egypt and Rockville, Maryland, USA: Ministry of Health and Population and ICF International.
- BackgroundEl-Masry R et al. Unmet need for family planning among women in rural Egypt International Journal of Community Medicine and Public Health. 2018 Apr;5(4):1252-1261
- Background: PubMed 24623902Ali M, Seuc A, Rahimi A, Festin M, Temmerman M. A global research agenda for family planning: results of an exercise for setting research priorities. Bull World Health Organ. 2014 Feb 1;92(2):93-8. doi: 10.2471/BLT.13.122242. Epub 2013 Nov 4.
- integration of family planning with immunization services by united states agency international developmentLink provided by the sponsor.
- Programming strategies for Postpartum Family PlanningLink provided by the sponsor.
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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.
maria tadros principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hany, Professor (01005236810 ext. 002, Ahmedhanyeg2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postpartum family planning utilization rate questionnaire (time frame: one year). 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 NCT03890705, which also lists 4 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 26 Mar 2019.