Oxytocin in Cesarean Delivery

• Status: Unknown status
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study the investigators perform the following steps:

1. The investigators validate a quantitative measure of uterine tone as our primary endpoint.

2. The investigators use this endpoint measure in order to determine equipotential doses of different tocotonic drug regimens, based on the ED50 for each.

3. Using equipontial ratios based on the ED50, the investigators compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Ergonovine; Oxytocin

Criteria

Inclusion Criteria:

• 80 healthy women presenting for elective repeat cesarean delivery under regional anesthesia.

• All women are ASA class 1-2, aged 18 - 45, with body weight 60-100 kg.

Exclusion Criteria:

• Obstetric risk factors: Pre-eclampsia, abnormalities of placentation (eg placenta accrete, placenta previa), amnionitis, multiple gestation, preterm delivery (< 37 completed weeks), more than three previous cesarean deliveries, previous history of ante-partum or post-partum hemorrhage.

• Maternal medical risk factors: Chronic hypertension, cardiac disease, intracranial pathology, known allergies to oxytocin or ergometrine, autoimmune disorders, SLE, coagulation defect or anticoagulation therapy, amnionitis.

• Women asking for cord blood donations are not included in this study due to the long elapsed time between delivery and the commencement of oxytocin.