Clinical trial NCT03598764: External Pop-out and Classic Fetal Head Extract During Cesarean Section
Official title: Feasibility and Outcomes of External Pop-out Versus Classic Fetal Head Extract During Cesarean Section: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 910
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean section is the delivery of the fetus through a surgical incision in the abdominal wall (laparotomy) and uterine wall (hysterotomy). The rate of cesarean delivery has increased progressively in the last decades until it becomes the most common operation performed all over the world.

A multitude of efforts had been done aiming at a reduction of cesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions. The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8%.

Delivery of the fetal head through the uterine incision is one of the major technical problems during elective cesarean section, especially when the presenting part is non-engaged. All of the previously described procedures, alternative to the classic manual head extraction, were inconclusive and not convincing to the obstetricians for routine use.

Also, no reported well-designed trials favor one of them over other. Application of vacuum cup, use of forceps blade, increasing fundal pressure and making additional uterine incisions were previously reported as alternative techniques. None of them gain any popularity or proved to be used as a basic step during cesarean section, besides many complications were reported due to their use on mothers and infants.

The vulnerability of the lower uterine segment for tears is related to the stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.

As with any surgical operation, anticipating difficulties during cesarean delivery and avoiding these difficulties is always the greatest practice. Although much has been written about techniques for managing difficult head extraction during vaginal deliveries, the reports addressed the management of difficult head delivery during cesarean section in literature are scarce.

The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment. This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection, adhesion and blood transfusion. Adherence to the available the generated good quality evidence bases practice in cesarean section is anticipated to decrease such morbidities.

The idea of the present technique was derived from the fact that during vaginal delivery the main task of the obstetrician is to support the perineum while the fetal head extends to get out through birth canal.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women in single, living, term (\>37 weeks), cephalic fetus.
2. Women eligible for elective Cesarean section.

Exclusion Criteria:

1. Multiple gestations
2. Placenta previa
3. Fetal congenital anomalies as hydrocephalus
4. Intrauterine fetal death.
5. US evidence anhydramnios

Primary outcomes:
measure: Number of women developed uterine tears
timeFrame: 5 minute
Secondary outcomes:
measure: Time of head extraction (minutes)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References: