Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

Placenta Previa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725553
• Other study ID #: aswu 192/7/18
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Previa

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with postpartum hemorrhage	blood loss > 1000ml measured by direct and gravimetric methods	6 hours post operative
Secondary	intraoperative blood loss	amount of blood loss during cesarean section	during the operation
Secondary	The number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	24 hours post operative
Secondary	need of extra surgical maneuvers	internal iliac ligation or hysterectomy	during the operation