Hand Forceps vs. Conventional One-hand Technique for Fetal Head Extraction During Cesarean Section (NCT04159857) | Clinical Trial Compass
UnknownNot Applicable
Hand Forceps vs. Conventional One-hand Technique for Fetal Head Extraction During Cesarean Section
United States52 participantsStarted 2020-01-28
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.