Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

Aswan University Hospital

Status: Completed

Conditions: Placenta Previa

Treatments: Drug: Placebo; Drug: Intramyometrial Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT03725553

aswu 192/7/18

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Intramyometrial Vasopressin

Experimental group

Description:

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.

Treatment:

Drug: Intramyometrial Vasopressin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo