Natural Cesarean SectionNCT02479282
Effect of Natural Cesarean Section on Breastfeeding
A study testing natural cesarean section and traditional cesarean section in people with Natural Cesarean Section, run by Ain Shams University.
Trial summary
Effect of natural cesarean section in comparison to traditional cesarean section on maternal and fetal recovery. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Natural Cesarean Section
- What is being tested?
- natural cesarean section and traditional cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Feb 2016
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primigravida or para one section
- full term
- cephalic
- single baby
- average weight
- spinal anathesia
Who cannot join
- High risk pregnancy.
- Women with known or suspected fetal malformation.
- Women with uterine malformations.
- Breech or transverse lie.
- Emergency caesarean section.
- Previous two or more caesarean section
About this study
Official title: Effect of Natural Cesarean Section in Comparison to Traditional Cesarean Section on Maternal and Fetal Recovery
Effect of natural cesarean section in comparison to traditional cesarean section on maternal and fetal recovery.
- Conditions
- Natural Cesarean Section
- Being tested
- natural cesarean section, traditional cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural cesarean sectionProcedure or surgery
traditional cesarean sectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| group A | Other | natural cesarean section Receives: Procedure: natural cesarean section |
| group B | Other | traditional cesarean section Receives: Procedure: traditional cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to start breastfeeding
Measured: 3 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer mohamed ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479282
- Sponsor's protocol ID
- Nsc_123
- Status last verified
- Jun 2015
- First submitted
- 13 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Natural Cesarean Section in Comparison to Traditional Cesarean Section on Maternal and Fetal Recovery
- ClinicalTrials.gov ID
- NCT02479282
- Acronym / sponsor ID
- Nsc_123
- Conditions
- Natural Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 24 Jun 2015 (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.
Effect of natural cesarean section in comparison to traditional cesarean section on maternal and fetal recovery.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Other | Procedure: natural cesarean sectionnatural cesarean section |
| group B | Other | Procedure: traditional cesarean sectiontraditional cesarean section |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- primigravida or para one section
- full term
- cephalic
- single baby
- average weight
Key exclusion criteria (6 listed)
- High risk pregnancy.
- Women with known or suspected fetal malformation.
- Women with uterine malformations.
- Breech or transverse lie.
- Emergency caesarean section.
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 |
|---|---|---|
| natural cesarean section | Procedure or surgery | group A |
| traditional cesarean section | Procedure or surgery | group B |
Primary outcome
time to start breastfeeding
Time frame: 3 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing natural cesarean section and traditional cesarean section in people with Natural Cesarean Section, run by Ain Shams University.
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 6 inclusion and 6 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
time to start breastfeeding (time frame: 3 hrs). 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 24 Jun 2015.