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

B

Bezmialem Vakif University

Status

Completed

Conditions

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

Treatments

Other: before uterine incision oxytocin
Other: after clamping the umbilical cord oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT03967171
BezmialemVU Oxytocin effect

Details and patient eligibility

About

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

Full description

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.

Enrollment

101 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

101 participants in 2 patient groups

before uterine incision oxytocin group
Experimental group
Description:
IV infusion of 20 IU of oxytocin started before uterine incision
Treatment:
Other: before uterine incision oxytocin
after clamping the umbilical cord oxytocin group
Active Comparator group
Description:
IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord
Treatment:
Other: after clamping the umbilical cord oxytocin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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