Placenta Previa
Conditions
Keywords
vasopressin, placenta previa, postpartum hemorrhage
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).
Interventions
DRUGIntramyometrial 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.
DRUGPlacebo
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.
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with postpartum hemorrhage | 6 hours post operative | blood loss \> 1000ml measured by direct and gravimetric methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | during the operation | amount of blood loss during cesarean section |
| The number of participant needed for blood transfusion | 24 hours post operative | Calculation of the number of participant needed for blood transfusion |
| need of extra surgical maneuvers | during the operation | internal iliac ligation or hysterectomy |
Countries
Egypt
Outcome results
None listed