Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

A Randomized Clinical Trial Examines the Efficacy of Intra-myometrial Local Injection of Vasopressin to Reduces the Blood Loss During Cesarean Section in Placenta Previa

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.

Study Overview

• Status: Completed
• Conditions: Placenta Previa
• Intervention / Treatment: Drug: Intramyometrial Vasopressin; Drug: Placebo

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.; Other Names: Experimental
PLACEBO_COMPARATOR: 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.	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.; Other Names: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with postpartum hemorrhage	blood loss > 1000ml measured by direct and gravimetric methods	6 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	amount of blood loss during cesarean section	during the operation
The number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	24 hours post operative
need of extra surgical maneuvers	internal iliac ligation or hysterectomy	during the operation

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (ACTUAL): October 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: postpartum hemorrhage; vasopressin; placenta previa
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: aswu 192/7/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No