The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery

NCT ID: NCT03967171

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-07-01

Brief Summary

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This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section

Detailed Description

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Postpartum hemorrhage (PPH) is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. The average blood loss during cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery. Worldwide, the most commonly used uterotonic for the prevention of PPH is oxytocin. Several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects. In the current study, we tested the hypothesis that initiating IV oxytocin infusion earlier before uterine incision would induce a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the same dose administered after delivery of the fetus.

Conditions

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Cesarean Section Complications Postpartum Hemorrhage Blood Loss, Surgical Blood Loss, Postoperative Postoperative Pain Atony, Uterine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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before uterine incision oxytocin group

IV infusion of 20 IU of oxytocin started before uterine incision

Group Type EXPERIMENTAL

before uterine incision oxytocin

Intervention Type OTHER

blood loss during elective cesarean section

after clamping the umbilical cord oxytocin group

IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord

Group Type ACTIVE_COMPARATOR

after clamping the umbilical cord oxytocin

Intervention Type OTHER

blood loss during elective cesarean section

Interventions

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before uterine incision oxytocin

blood loss during elective cesarean section

Intervention Type OTHER

after clamping the umbilical cord oxytocin

blood loss during elective cesarean section

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* single fetus at term \>37 weeks of gestational age

Exclusion Criteria

* history of previous cesarean section
* history of previous uterine surgery
* multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
* women at high risk for uterine atony such as anemia (Hb \< 8 gm/dL)
* uterine atony history
* gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bezmialem Vakıf University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BezmialemVU Oxytocin effect

Identifier Type: -

Identifier Source: org_study_id

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