Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa
Condition: Placenta Previa
MeSH terms: Placenta Previa
Study type: Interventional

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).
    

Intervention name(s): Intramyometrial Vasopressin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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 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 intervention name(s): Experimental; Placebo Comparator
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vasopressin; placenta previa; postpartum hemorrhage