Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

NCT03725553 | Completed DMC

• 1 other identifier: aswu 192/7/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Previa

Keywords

vasopressin; placenta previa; postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• Number of Participants with postpartum hemorrhage

  blood loss \> 1000ml measured by direct and gravimetric methods

  6 hours post operative

Secondary Outcomes (3)

• intraoperative blood loss

  during the operation

• The number of participant needed for blood transfusion

  24 hours post operative

• need of extra surgical maneuvers

  during the operation

Study Arms (2)

Intramyometrial Vasopressin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Intramyometrial Vasopressin 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.

Also known as: Experimental

Intramyometrial Vasopressin

Placebo 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.

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant patients scheduled for cesarean section for placenta previa
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Placenta Previa; Diabetes Insipidus; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: October 31, 2018
• Study Start: December 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: August 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)