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Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

Primary Purpose

Placenta Previa

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intramyometrial Vasopressin
Placebo
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa focused on measuring vasopressin, placenta previa, postpartum hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Aswan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intramyometrial Vasopressin

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of Participants with postpartum hemorrhage
blood loss > 1000ml measured by direct and gravimetric methods

Secondary Outcome Measures

intraoperative blood loss
amount of blood loss during cesarean section
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
need of extra surgical maneuvers
internal iliac ligation or hysterectomy

Full Information

First Posted
October 28, 2018
Last Updated
August 6, 2021
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03725553
Brief Title
Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
Keywords
vasopressin, placenta previa, postpartum hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intramyometrial Vasopressin
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Intramyometrial Vasopressin
Other Intervention Name(s)
Experimental
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with postpartum hemorrhage
Description
blood loss > 1000ml measured by direct and gravimetric methods
Time Frame
6 hours post operative
Secondary Outcome Measure Information:
Title
intraoperative blood loss
Description
amount of blood loss during cesarean section
Time Frame
during the operation
Title
The number of participant needed for blood transfusion
Description
Calculation of the number of participant needed for blood transfusion
Time Frame
24 hours post operative
Title
need of extra surgical maneuvers
Description
internal iliac ligation or hysterectomy
Time Frame
during the operation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant patients scheduled for cesarean section for placenta previa
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

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