Oxytocin in Cesarean Delivery

NCT ID: NCT01236482

Last Updated: 2010-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

Brief 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.

Detailed Description

Obstetric hemorrhage is associated with severe maternal morbidityש and maternal death. The use of tocotonic drugs following delivery is routine practice as part of the active management of the third stage of labor, to increase uterine tone and reduce blood loss. However, the use of these drugs is not without side effects and complications. Oxytocin causes profound vasodilatation, hypotension and increased cardiac output and has been associated with chest pain, reduced arterial oxygen saturation and ST segment changes on ECG. Ergometrine, on the other hand, causes systemic vasoconstriction and hypertension, and reduced cardiac output. As oxytocin and ergometrine are associated with opposing hemodynamic sequelae, there is a rationale to justify the co-administration of both of these drugs in an attempt to cancel out their side effects.

No clinical studies have attempted to titrate the dose of tocotonic drugs against a quantified measure of uterine tone. As a consequence, comparisons of the hemodynamic side effects of oxytocin and other tocotonic agents (particularly ergometrine) have not been based on a knowledge of equipotential doses, making the rational comparison of side effects impossible.

In this study we 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 we perform the following steps:

1) We validate a quantitative measure of uterine tone as our primary endpoint. 2) We 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, we compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured to enable pharmacokinetic-pharmacodynamic assessments to be made.

Conditions

Post Partum Hemorrhage

Keywords

Pregnancy; Postpartum hemorrhage; Uterine tone; Oxytocin; Ergometrine; Pharmacokinetic-pharmacodynamic analysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin

Group Type: ACTIVE_COMPARATOR

Oxytocin versus oxytocin-ergometrine

Intervention Type: DRUG

Group 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study

Oxytocin - ergometrine

Group Type: EXPERIMENTAL

Oxytocin versus oxytocin-ergometrine

Intervention Type: DRUG

Group 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study

Interventions

Oxytocin versus oxytocin-ergometrine

Group 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hadassah Hebrew University Medical Center

Locations

Hadassah Hebrew University Medical Center

Jerusalem, , Israel

Countries

Israel

Facility Contacts

Yehuda Ginosar, MBBS

Role: primary

Other Identifiers

oxytocined50-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id