Push With Lower Uterine Segment Support

NCT02934516 | Unknown DMC

• 1 other identifier: PLUS-DIH-02
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dystocia

Keywords

Obstructed labor; C section. push method; reverse breech

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Cesarean section operative time

  Time from incision to closure of the skin (within 24 hours of recruitment)

• Intra-operative blood loss

  During Cesarean section only

• The incidence of postpartum hemorrhage

  During the first 24 hours post-operative

• Incidence of blood transfusion

  During surgery and within the first 24 hours postoperative

• Fetal traumatic birth injuries

  During Cesarean section (fetal delivery)

Study Arms (2)

Disimpaction with lower uterine support

EXPERIMENTAL

Cesarean section with support of the lower uterine segment

Procedure: Cesarean section

Classic push method

ACTIVE COMPARATOR

Cesarean section with push method

Procedure: Cesarean section

Interventions

Cesarean section PROCEDURE

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

Classic push method; Disimpaction with lower uterine support

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead
• Aswan University: collaborator

Related Publications (4)

• Dolea C, AbouZahr C. Global burden of obstructed labour in the year 2000. World Health Organization (WHO), Geneva, Switzerland. 2003 Jul;1:17.

  BACKGROUND

• Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour. Br Med Bull. 2003;67:191-204. doi: 10.1093/bmb/ldg018.

  PMID: 14711764 BACKGROUND

• 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.

  PMID: 6702937 BACKGROUND

• 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.

  PMID: 23271386 BACKGROUND

MeSH Terms

Conditions

Dystocia

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmed Nasr, MBBCh, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Sherif A. Shazly, MBBCh, MSc

CONTACT

+15075131392; shazly.sherif2020@gmail.com

Amr Shehata, MBBCh, MD

CONTACT

Love_like902@Yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.Ch, M.Sc

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: May 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share