Recruiting

Hand Forceps vs. Conventional Technique

Sponsor:

The Reading Hospital and Medical Center

Code:

NCT04159857

Conditions

Pregnancy Related

Delivery Complication

Cesarean Delivery Affecting Fetus

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Fetal head extraction technique during the cesarean section

Study Details

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

Study ID

NCT04159857

Start date

Jan 28, 2020

Status verified date

Mar, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: One-hand

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.

experimental: Two-hand

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.

Interventions

Fetal head extraction technique during the cesarean section

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

Primary outcome measure

  • Time needed for fetal head delivery [ Time Frame: 2 year ]

Central Contacts and Locations

Central contacts

Xuezhi (Daniel) Jiang, MD

4846288981daniel.jiang@towerhealth.org

Locations

Reading Hospital Labor & Delivery

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Xuezhi Jiang, MD

daniel.jiang@towerhealth.org

More Information

Sponsor

The Reading Hospital and Medical Center

Last update posted

Apr 6, 2022

Last verified

Mar, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Reading Hospital and Medical Center on 2022-04-06.