Hand Forceps vs. Conventional One-hand Technique for Fetal Head Extraction During Cesarean Section

NCT04159857 | Unknown

• 1 other identifier: IRB 028-18
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the efficacy and safety of an innovative two-hand (hand forceps) fetal head extraction technique during the transverse cesarean sections (LTCS) by comparing with the conventional one-hand technique used worldwide for centuries. The primary research question of the study is whether two-hand fetal head extraction technique results in quicker head delivery. The secondary research question is whether two-hand technique would cause increased incidence of extension of uterine incision as well as other adverse events while compared to conventional one-hand technique. Our hypothesis is that two-hand technique would speed up fetal head delivery without increasing the risk of extension of uterine incision as well as other adverse events, in the meantime, maternal discomfort will be significantly reduced since fundal pressure will not be required during the fetal head delivery.

Conditions

Pregnancy Related; Delivery Complication; Cesarean Delivery Affecting Fetus

Keywords

hand forceps, cesarean section, one-hand technique, two-hand technique, fetal head extraction

Outcome Measures

Primary Outcomes (1)

• Time needed for fetal head delivery

  Time from entry of uterus to delivery of fetal head (U-D interval)

  2 year

Secondary Outcomes (1)

• Extension of hysterotomy

  2 year

Study Arms (2)

One-hand

ACTIVE COMPARATOR

During LTCS, the fetal head traditionally is delivered by one-hand manual extraction (a surgeon inserts one hand into the uterus via the hysterotomy and lifts the fetal head out of maternal pelvis, subsequently significant abdominal pressure is required to squeeze the fetal head out of hysterotomy) along with application of significant abdominal/fundal pressure.

Procedure: Fetal head extraction technique during the cesarean section

Two-hand

EXPERIMENTAL

An innovative approach to manual head extraction, with surgeon's both hands formed as a pair of forceps, has been used by the PI of this study for years during the LTCS for head extraction in the difficult situations described above without complication, often time it was used after one hand approach failed to deliver the infant, vacuum/forceps and abdominal pressure usually was not needed in these cases.

Procedure: Fetal head extraction technique during the cesarean section

Interventions

Fetal head extraction technique during the cesarean section PROCEDURE

see above for the description about one-hand and two-hand fetal head extraction technique

One-hand; Two-hand

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age (GA) 37 weeks or above with cephalic presentation
• Planned low transverse uterine incision
• Cervical dilation \<= 6cm
• Station \< 0.

You may not qualify if:

• Preterm GA \<37 weeks
• Planned classical C-section
• Unable or unwilling to afford abdominal pressure during the delivery of fetal head
• Advanced cervical dilation \>6cm
• Station \>=0

Sponsors & Collaborators

• The Reading Hospital and Medical Center: lead

Study Sites (1)

Reading Hospital Labor & Delivery

West Reading, Pennsylvania, 19611, United States

RECRUITING

Related Publications (1)

• Arad I, Linder N, Bercovici B. Vacuum extraction at cesarean section--neonatal outcome. J Perinat Med. 1986;14(2):137-40. doi: 10.1515/jpme.1986.14.2.137.

  PMID: 3735047 RESULT

Study Officials

• Xuezhi (Daniel) Jiang, MD

  Reading Hospital of Tower Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuezhi (Daniel) Jiang, MD

CONTACT

4846288981; daniel.jiang@towerhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Clerkship Director of OBGYN

Model Details: Arm 1: Fetal head is extracted by conventional one-hand (in hysterotomy) technique during the C-section Arm 2: Fetal head is extracted by an innovative two-hand (in hysterotomy) technique during the C-section

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: January 28, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)