Clinical trial NCT02934516: Push With Lower Uterine Segment Support
Official title: Delivery of Impacted Fetal Head During Cesarean Section for Obstructed Labor: Push Method Versus Abdominal Disimpaction With Lower Uterine Segment Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dystocia
Keywords: Obstructed labor
C section. push method
reverse breech
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Aswan University
First posted: 2016-10-17
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Extension of uterine incision
timeFrame: During delivery of the fetus
measure: Length of extension of uterine incision
timeFrame: During delivery of the fetus
measure: Injury of the vagina
timeFrame: During delivery of the fetus
measure: Injury of the bladder
timeFrame: During delivery of the fetus
measure: Injury of the ureter
timeFrame: During delivery of the fetus
Secondary outcomes:
measure: Cesarean section operative time
timeFrame: Time from incision to closure of the skin (within 24 hours of recruitment)
measure: Intra-operative blood loss
timeFrame: During Cesarean section only
measure: The incidence of postpartum hemorrhage
timeFrame: During the first 24 hours post-operative
measure: Incidence of blood transfusion
timeFrame: During surgery and within the first 24 hours postoperative
measure: Fetal traumatic birth injuries
timeFrame: During Cesarean section (fetal delivery)
measure: APGAR score
timeFrame: At 1 and 5 minutes after delivery of the newborn
measure: Need for neonatal admission to neonatal intensive care unit
timeFrame: Within 24 hours of delivery of the newborn
measure: Postoperative infections
timeFrame: 1 week of postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed Nasr, MBBCh, MD
role: STUDY_DIRECTOR
References:
citation: Dolea C, AbouZahr C. Global burden of obstructed labour in the year 2000. World Health Organization (WHO), Geneva, Switzerland. 2003 Jul;1:17.
citation: Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour. Br Med Bull. 2003;67:191-204. doi: 10.1093/bmb/ldg018.
citation: Landesman R, Graber EA. Abdominovaginal delivery: modification of the cesarean section operation to facilitate delivery of the impacted head. Am J Obstet Gynecol. 1984 Mar 15;148(6):707-10. doi: 10.1016/0002-9378(84)90551-9.
citation: Shazly SA, Elsayed AH, Badran SM, Abdel Badee AY, Ali MK. Abdominal disimpaction with lower uterine segment support as a novel technique to minimize fetal and maternal morbidities during cesarean section for obstructed labor: a case series. Am J Perinatol. 2013 Sep;30(8):695-8. doi: 10.1055/s-0032-1331031. Epub 2012 Dec 27.