Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorStanford University

About this trial

During standard cesarean deliveries, there are two ways that obstetricians repair the incision on the uterus (hysterotomy after delivery of the baby. One method involves lifting the uterus out of its regular place in the abdomen to repair the incision (uterine exteriorization for repair). The second method involves leaving the uterus inside the abdomen to repair the uterus (in situ repair). Both of these methods are regularly used by obstetricians during cesarean deliveries, and it is not currently known if one has benefits over the other. Currently, surgeons use both methods, but lifting the uterus out of its place is slightly more common. In this study, participants will be randomly assigned to have one of these techniques performed during their surgery. Researchers will be investigating whether one technique or the other leads to better contraction of the uterus after delivery, less bleeding, less intra-operative nausea/vomiting, or a better patient experience than another.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-55

Undergoing cesarean section

Disqualifiers

Patient age <18 or >55

Case urgency deemed too great for consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test Intervention: In Situ Repair

    Procedure/Surgery

    Repair of the hysterotomy (uterine incision) within the abdomen (in situ) after delivery of the infant during a cesarean section.

  • Comparator Intervention: Exteriorization

    Procedure/Surgery

    The uterus will be temporarily exteriorized from the abdomen for repair of the hysterotomy (uterine incision) after delivery of the infant in a cesarean section.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Uterine ExteriorizationActive comparator 1 intervention
Group B: In Situ RepairExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Compliance/Feasibility

Percentage of consented cesarean participants who were successfully treated as randomly allocated in each arm

Time frame
Duration of the study, approximately 2 years
2

Efficacy Signal

Mean quantitative blood loss, analyzed after log transformation in a regression model that adjusts for cesarean group (scheduled, 1st stage, and 2nd stage)

Time frame
Duration of the study, approximately 2 years

Secondary outcomes

1

Feasibility: Enrollment

Number of consented participants who underwent cesarean section and Obstetrician agreed to randomization at huddle

Time frame
Duration of the study, approximately 2 years
2

10 Minute Uterine Tone Score between groups

Uterine tone score 10 minutes after delivery of the placenta between groups, measured on a scale of 0 to 10, with "0" representing "no tone" and "10" representing excellent tone.

Time frame
Duration of the study, approximately 2 years
3

Incidence of Intraoperative Breakthrough Pain between groups

Time frame
Duration of the study, approximately 2 years
4

Incidence of Intraoperative Vomiting between groups

Time frame
Duration of the study, approximately 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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