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Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

NCT03725553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-08-09

No results posted yet for this study

Summary

Placenta previa can have serious adverse consequences for the mother, including an increased risk of maternal mobility, antenatal and intrapartum hemorrhage, and the mother may, therefore, require a blood transfusion or even an emergency hysterectomy. Although it is a relatively rare condition with an overall incidence of 0.28-2.0% of all deliveries, it has been suggested that the incidence of placenta previa is increasing. Many gynecological surgeons use a local injection of vasopressin, which is a known peripheral vasoconstrictor, at the time of laparoscopic myomectomy to decrease blood loss. In addition, the useful role for local infiltration of vasopressin to arrest hemorrhage from the placental bed has been demonstrated in several obstetrical case reports. The vasopressin V1α receptor has been demonstrated to be present in the myometrium of both non-pregnant and pregnant women and contributes to myometrial contraction. Therefore, the investigators evaluated the effect of local injection of vasopressin on the blood loss and secondary impact on complications during cesarean section in cases of placenta previa.

Conditions

  • Placenta Previa

Interventions

DRUG

Intramyometrial Vasopressin

a bolus injection of vasopressin (4 IU) diluted to 2 mL with saline into the myometrium of the placental bed during slow (30-seconds) immediately after delivery, as soon as the umbilical cord was clamped.

DRUG

Placebo

the group received a 10-mL bolus injection of saline into the myometrium during slow (30-seconds)as soon as the umbilical cord was clamped.

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • hany f sallam, md · Aswan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2021-06-30
Completion
2021-08-01

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03725553 on ClinicalTrials.gov