Vaginal DeliveryNCT03121274
Early Versus Delayed Pushing in the Second Stage of Labor
A study testing vaginal delivery in people with Vaginal Delivery, run by Cairo University at 1 site in Egypt.
Trial summary
Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- vaginal delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2017to 25 Sep 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy women
- Gestational age 36 to 40 weeks
- singleton pregnancy
Who cannot join
- women indicated for cesarean section
- Medical complications of pregnancy as hypertensive disorders or Diabetes Mellitus
- Fetal distress
- Epidural anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.
Read the detailed description
Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.
Oxytocin was allowed in both group and fetus was monitored with CTG.
- Conditions
- Vaginal Delivery
- Being tested
- vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal deliveryProcedure or surgery
vaginal delivery is carried by an expert obstetrician and the need for forceps or ventose is recorded
| Study group | Role | What they receive |
|---|---|---|
| Early pushing during vaginal delivery | Active comparator | patients are allowed to push within one hour after full cervical dilatation whether the vertex was visible or not Receives: Procedure: vaginal delivery |
| Delayed pushingduring vaginal delivery | Active comparator | patients here are asked not to push for maximum of 3 hours or start pushing when the vertex was visible Receives: Procedure: vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful vaginal delivery
success of vaginal delivery
Measured: within 3 hours from full cervical dilatation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start10 Aug 2017
- Primary completion1 Aug 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121274
- Sponsor's protocol ID
- 166
- Status last verified
- Nov 2018
- First submitted
- 11 Apr 2017
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Pushing in the Second Stage of Labor
- ClinicalTrials.gov ID
- NCT03121274
- Acronym / sponsor ID
- 166
- Conditions
- Vaginal Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 20 Apr 2017 (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.
Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.
Detailed description
Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.
Oxytocin was allowed in both group and fetus was monitored with CTG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early pushing during vaginal delivery | Active comparator | Procedure: vaginal deliverypatients are allowed to push within one hour after full cervical dilatation whether the vertex was visible or not |
| Delayed pushingduring vaginal delivery | Active comparator | Procedure: vaginal deliverypatients here are asked not to push for maximum of 3 hours or start pushing when the vertex was visible |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women
- Gestational age 36 to 40 weeks
- singleton pregnancy
Key exclusion criteria (4 listed)
- women indicated for cesarean section
- Medical complications of pregnancy as hypertensive disorders or Diabetes Mellitus
- Fetal distress
- Epidural anaesthesia
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 |
|---|---|---|
| vaginal deliveryvaginal delivery is carried by an expert obstetrician and the need for forceps or ventose is recorded | Procedure or surgery | Delayed pushingduring vaginal delivery, Early pushing during vaginal delivery |
Primary outcome
successful vaginal delivery
Time frame: within 3 hours from full cervical dilatation
success of vaginal delivery
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 5 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal delivery in people with Vaginal Delivery, run by Cairo 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 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: finished, as of the sponsor's last update on 5 Nov 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?
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?
successful vaginal delivery (time frame: within 3 hours from full cervical dilatation). 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 5 Nov 2018.