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Completed

NCT Number: NCT03725553

Intra-myometrial Vasopressin 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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Experimental

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.

Other names: Placebo Comparator

Primary outcomes

  1. Number of Participants with postpartum hemorrhage

    Time frame: 6 hours post operative

    blood loss > 1000ml measured by direct and gravimetric methods

Secondary outcomes

  1. intraoperative blood loss

    Time frame: during the operation

    amount of blood loss during cesarean section

  2. The number of participant needed for blood transfusion

    Time frame: 24 hours post operative

    Calculation of the number of participant needed for blood transfusion

  3. need of extra surgical maneuvers

    Time frame: during the operation

    internal iliac ligation or hysterectomy

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2018
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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