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

NCT04159857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-04-06

No results posted yet for this study

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

Interventions

PROCEDURE

Fetal head extraction technique during the cesarean section

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

Sponsors & Collaborators

  • The Reading Hospital and Medical Center

    lead OTHER

Principal Investigators

  • Xuezhi (Daniel) Jiang, MD · Reading Hospital of Tower Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159857 on ClinicalTrials.gov