Push With Lower Uterine Segment Support (PLUS)

Assiut University

Status: Unknown

Conditions: Dystocia

Treatments: Procedure: Cesarean section

Study type: Interventional

Funder types: Other

Identifiers

NCT02934516

PLUS-DIH-02

Details and patient eligibility

About

The study aims to compare maternal and early neonatal outcomes of abdominal disimpaction with lower uterine segment support in comparison to the classic "push" method for delivery of impacted fetal head during Cesarean section for obstructed labor.

Full description

Obstructed labor refers to failure of labor progress in spite of good uterine contractions and is attributed to mismatch between the size of the presenting part of the fetus and the mother's pelvis. Approximately 8% of maternal deaths worldwide are attributed to obstructed labor and subsequent puerperal infection, uterine rupture, and postpartum hemorrhage.

In these situations, Cesarean section could minimize maternal and neonatal morbidity. However, Cesarean section is challenging when the head is deeply impacted and is associated with high risk of maternal injuries and perinatal injuries. The most common complication is extension of uterine incision which could involve the vagina, bladder, ureters and broad ligament. Neonates are also at risk of skull fractures, cephalhematoma, and subgaleal hematoma mainly due to manipulations. Currently, the most popular approaches for fetal head delivery are the push and pull methods. Although push method seems to be more convenient and does not necessitate extensive experience, it is more significantly associated with extension than the pull method. Although pull method seems to be more safe, it is more difficult to perform and usually warrants an aggressive uterine incision to deliver the fetus. In 2013, investigators published a case series on abdominal disimpaction with lower uterine segment support which basically allows obstetricians to deliver the fetal head through a transverse uterine incision with minimal risk of extensions and neonatal complications. In this study, investigators aim to validate this approach in comparison to the classic push method.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Singleton term pregnancy, 37 to 42 weeks of gestation.
• Cephalic presentation.
• The cervix is fully dilated.
• Ruptured membranes.
• Adequate uterine contractions.
• Impacted fetal head in maternal pelvis

Exclusion criteria

• Intrauterine fetal death
• Major fetal anomalies
• Non-cephalic presentation
• Multiple pregnancy
• Preterm caesarean < 37 weeks
• Abnormal placentation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Disimpaction with lower uterine support

Experimental group

Description:

Cesarean section with support of the lower uterine segment

Treatment:

Procedure: Cesarean section

Classic push method

Active Comparator group

Description:

Cesarean section with push method

Treatment:

Procedure: Cesarean section