Reverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix

NCT ID: NCT05707650

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Management of impacted fetal head during second stage cesarean requires careful and gentle attention to various surgical steps for delivery of a fetus without adverse maternal and neonatal outcomes, mostly by an experienced surgeon as in such situations, the lower uterine segment may be over-distended and indistinguishable from the vagina. Therefore, the uterine incision may inadvertently be placed too low, or in the vagina.

Also, it may be difficult for the operating surgeon to maneuver his hand below the deeply engaged fetal head, which may be further compounded by the presence of molding and edema on the fetal head (caput succedaneum).

This prospective controlled study was conducted at labor ward of department of obstetrics and gynecology at Ain Shams University Maternity Hospital to compare between the two techniques. A total of 70 pregnant women were enrolled and divided into two equal groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructed Labor at Second Stage of Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women allocated to this group will deliver by using reverse breech extraction technique.

Group Type ACTIVE_COMPARATOR

reverse breech extraction technique or push technique

Intervention Type PROCEDURE

using reverse breech extraction technique or push technique for disimpaction of fetal head during cs of a fully dilated cervix

Women allocated to this group will deliver by using Push technique.

Group Type ACTIVE_COMPARATOR

reverse breech extraction technique or push technique

Intervention Type PROCEDURE

using reverse breech extraction technique or push technique for disimpaction of fetal head during cs of a fully dilated cervix

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

reverse breech extraction technique or push technique

using reverse breech extraction technique or push technique for disimpaction of fetal head during cs of a fully dilated cervix

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • Singleton pregnancies.

* Cephalic presentation will undergo cesarean section in advanced labor with the fetal head deeply engaged in the pelvis defined as fully dilated cervix and vertex at or below zero station

Exclusion Criteria

* • Twins Pregnancies.

* Breech or transverse presentation.
* Woman has other obstetric indication to cs ex, fetal distress.
* Woman has risk factor for bleeding ex, bleeding disorders
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ebtihal Ahmed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medecine At Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ebtihal ahmed, baccalaureus

Role: CONTACT

01062477324

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ebtihal ahmed, baccalarous

Role: primary

01062477324

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU MS492/2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Amnioreduction in Polyhydramnios
NCT07067593 NOT_YET_RECRUITING
R. I. S. POS. T. A
NCT01991665 UNKNOWN NA