Push With Lower Uterine Segment Support (PLUS)

Delivery of Impacted Fetal Head During Cesarean Section for Obstructed Labor: Push Method Versus Abdominal Disimpaction With Lower Uterine Segment Support

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.

Study Overview

• Status: Unknown
• Conditions: Dystocia
• Intervention / Treatment: Procedure: Cesarean section

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherif A. Shazly, MBBCh, MSc; Phone Number: +15075131392; Email: shazly.sherif2020@gmail.com
• Study Contact Backup: Name: Amr Shehata, MBBCh, MD; Email: Love_like902@Yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Disimpaction with lower uterine support; Cesarean section with support of the lower uterine segment	Procedure: Cesarean section; Abdominal disimpaction with lower uterine segment support: the edge of the lower uterine segment is grasped by 3-4 modified Allies forceps (with broader jaws) applied along the lower edge of the incision until it is completely supported. These forceps are handled by the assistant, and gentle traction is applied upward, perpendicular to the uterine surface and away from the fetal head without excessive force. Accordingly, the hand of the surgeon could be inserted into the uterine cavity, and adequate space for manipulations is available without applying pressure on the lower segment. The fetal head is eventually grasped and delivered. Classic push method: delivering the head with assistance by pushing the fetal head vaginally
ACTIVE_COMPARATOR: Classic push method; Cesarean section with push method	Procedure: Cesarean section; Abdominal disimpaction with lower uterine segment support: the edge of the lower uterine segment is grasped by 3-4 modified Allies forceps (with broader jaws) applied along the lower edge of the incision until it is completely supported. These forceps are handled by the assistant, and gentle traction is applied upward, perpendicular to the uterine surface and away from the fetal head without excessive force. Accordingly, the hand of the surgeon could be inserted into the uterine cavity, and adequate space for manipulations is available without applying pressure on the lower segment. The fetal head is eventually grasped and delivered. Classic push method: delivering the head with assistance by pushing the fetal head vaginally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension of uterine incision	The incidence of extension of uterine incision	During delivery of the fetus
Length of extension of uterine incision	If extension of uterine incision happens, the length of extension will be measured	During delivery of the fetus
Injury of the vagina	Extension of uterine incision into the vagina	During delivery of the fetus
Injury of the bladder	Extension of uterine incision into the bladder	During delivery of the fetus
Injury of the ureter	Extension of uterine incision into the ureter	During delivery of the fetus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean section operative time	Duration of Cesarean section operation	Time from incision to closure of the skin (within 24 hours of recruitment)
Intra-operative blood loss	Amount of blood loss as estimated by suction device from incision to closure of the skin	During Cesarean section only
The incidence of postpartum hemorrhage	Loss of more than 500 ml during the first 24 hours after surgery and the management that will be done	During the first 24 hours post-operative
Incidence of blood transfusion	The incidence of blood transfusion due to significant blood loss (based on blood loss and clinical judgement "hypotension, tachycardia, pallor")	During surgery and within the first 24 hours postoperative
Fetal traumatic birth injuries	Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma	During Cesarean section (fetal delivery)
APGAR score		At 1 and 5 minutes after delivery of the newborn
Need for neonatal admission to neonatal intensive care unit		Within 24 hours of delivery of the newborn
Postoperative infections	Puerperal sepsis and Cesarean section wound infection	1 week of postpartum

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: Aswan University
• Investigators: Study Director: Ahmed Nasr, MBBCh, MD, Assiut University

Publications and helpful links

General Publications

• Dolea C, AbouZahr C. Global burden of obstructed labour in the year 2000. World Health Organization (WHO), Geneva, Switzerland. 2003 Jul;1:17.
• Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour. Br Med Bull. 2003;67:191-204. doi: 10.1093/bmb/ldg018.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (ESTIMATE): October 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Obstructed labor; C section. push method; reverse breech
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia
• Other Study ID Numbers: PLUS-DIH-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No