Improving Quality of LifeNCT02901639
Postpartum Contraception Counseling on the Rate of Unintended Pregnancy
A study testing counseling in people with Improving Quality of Life, run by Assiut University at 1 site in Egypt.
Trial summary
Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Improving Quality of Life
- What is being tested?
- counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to Nov 2018
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: above 18 years
- Primigravida
- Women who will accept to participate in
Who cannot join
- Women who are not intended to use contraception
- Multiparous
- Women who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abbas
Assiut, Cairo Governorate, 002
ahmed abbas, bmr90@hotmail.com
About this study
Official title: Influence of Immediate Postpartum Contraception Counseling on the Rate of Unintended Pregnancy in Primigravida: A Randomized Controlled Study
Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy also is a major health problem in the United States of America. In the 2002 National Survey of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies
- Conditions
- Improving Quality of Life
- Being tested
- counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselingOther
| Study group | Role | What they receive |
|---|---|---|
| counseling group | Experimental | will receive counseling about contraceptive methods using illustrations through postpartum interview with the study Receives: Other: counseling |
| NO counseling | No intervention | will not receive any counseling about contraceptive methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the rate of unintended pregnancy in both groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Quality of LifeStudies 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901639
- Sponsor's protocol ID
- PPCC
- Status last verified
- Jun 2018
- First submitted
- 10 Sep 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Immediate Postpartum Contraception Counseling on the Rate of Unintended Pregnancy in Primigravida: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02901639
- Acronym / sponsor ID
- PPCC
- Conditions
- Improving Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy also is a major health problem in the United States of America. In the 2002 National Survey of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| counseling group | Experimental | Other: counselingwill receive counseling about contraceptive methods using illustrations through postpartum interview with the study |
| NO counseling | No intervention | –will not receive any counseling about contraceptive methods |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: above 18 years
- Primigravida
- Women who will accept to participate in
Key exclusion criteria (3 listed)
- Women who are not intended to use contraception
- Multiparous
- Women who refuse to participate in the study
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 |
|---|---|---|
| counseling | Other | counseling group |
Primary outcome
The difference in the rate of unintended pregnancy in both groups
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling in people with Improving Quality of Life, 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: status not confirmed, as of the sponsor's last update on 27 Jun 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the rate of unintended pregnancy in both groups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2018.