An interventional study of Intramyometrial Vasopressin and Placebo in Placenta Previa, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Aswan University Hospital · Not applicable, Interventional, and Prevention
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.
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).
80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.
This study's enrollment of 120 is above the median of 109 across 45 interventional studies indexed under Placenta Previa.
Browse Placenta Previa studies →Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Number of Participants with postpartum hemorrhage
blood loss \> 1000ml measured by direct and gravimetric methods
Time frame: 6 hours post operative
intraoperative blood loss
amount of blood loss during cesarean section
Time frame: during the operation
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
Time frame: 24 hours post operative
need of extra surgical maneuvers
internal iliac ligation or hysterectomy
Time frame: during the operation
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2018 to primary completion in Jun 2021, 30 months.
Of 23 interventional studies with no phase under Placenta Previa, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 30 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Aswan University Hospital