Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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The study drug was administered immediately after delivery, as soon as the umbilical cord was clamped. The experimental group received a bolus injection of vasopressin (4 IU) diluted to 2 mL with saline into the myometrium of the placental bed during slow (30-seeconds) Conversely, the placebo group received a 10-mL bolus injection of saline into the myometrium during slow (30-seconds).

Conditions

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Placenta Previa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomized to two groups, patients according to a two -blocked randomization list which was coded (1 or 2) at 1:1 ratio. The study drug was administered immediately after delivery, as soon as the umbilical cord was clamped. The experimental group received a bolus injection of vasopressin (4 IU) diluted to 2 mL with saline into the myometrium of the placental bed during slow (30-s) Conversely, the placebo group received a 10-mL bolus injection of saline into the myometrium during slow (30-seconds).

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used.

Study Groups

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Intramyometrial Vasopressin

the experimental group received 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.

Group Type EXPERIMENTAL

Intramyometrial Vasopressin

Intervention Type DRUG

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Experimental Placebo Comparator

Eligibility Criteria

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Inclusion Criteria

* all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa and invited them to participate in the study. The placenta previa was defined as a placenta completely covering the cervical os in ultrasound examination

Exclusion Criteria

* Patients with a cardiac, hepatic, renal or thromboembolic disease.
* patients with the high possibility of the morbid adherent placenta.
* known coagulopathy
* those presented with severe antepartum hemorrhage will be excluded
* hypersensitivity or contraindications of use of vasopressin
* patient refuses to consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No