Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364098
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-03-24
Brief Title:
Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study design
A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital Cairo University
Population of study
192 pregnant women at the age range from 20 to 35 years with BMI 30kgm2 presenting with a full-term singleton healthy living fetus gestational age 39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan and candidate for elective cesarean delivery Previous one or two cesarean section were included in our study Patients with uterine over distension as due to multiple pregnancies or polyhydramnios multipara parity 3 women with uterine fibroids antepartum hemorrhage presentation such as placenta previa placental abruption or vasa previa moderate to severe anemia with hemoglobin level 9mgdl patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias hypertension cardiovascular DM hepatic or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone antacids containing magnesium were excluded from our study
A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital Cairo University
Population of study
192 pregnant women at the age range from 20 to 35 years with BMI 30kgm2 presenting with a full-term singleton healthy living fetus gestational age 39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan and candidate for elective cesarean delivery Previous one or two cesarean section were included in our study Patients with uterine over distension as due to multiple pregnancies or polyhydramnios multipara parity 3 women with uterine fibroids antepartum hemorrhage presentation such as placenta previa placental abruption or vasa previa moderate to severe anemia with hemoglobin level 9mgdl patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias hypertension cardiovascular DM hepatic or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone antacids containing magnesium were excluded from our study
Detailed Description:
After receiving the research approval of the Scientific and Ethical Committee of the Obstetrics and Gynecology department Cairo University the study purpose was clarified simply and in a lay Arabic speech to all women before registering in the study and the enrolled women signed informed consent form Pregnant women who met all the inclusion criteria were evaluated for enrollment Prior to the study randomization schedules created by computer program were designed and settled in serially numbered secured opaque envelopes Simple randomization was applied at one to one ratio within both groups The recruited women - after giving consent for participation- opened the sealed randomization envelopes for revealing the allocation
All participants were subjected to Comprehensive history taking including obstetric medical and surgical history
General examination excluding the presence of any abnormalities Systematic obstetrical examinations A transabdominal ultrasound to confirm the diagnosis and evaluation of fetal condition
A blood sample collected for complete blood counting coagulation studies liver and kidney function tests
All women were subjected to elective lower segment cesarean section by the same team under spinal anesthesia and antibiotic prophylaxis according hospital protocol
Women were divided into two equal groups
Group A 96 women receiving 400 mcg intrauterine misoprostol IV oxytocin Group B 96 women receiving 400 mcg sublingual misoprostol IV oxytocin Both groups were subjected to the same preparation All cesarean deliveries were performed by a senior obstetrics and gynecology resident and the elective sections were performed at 39th weeks gestation adopting the following operative steps transverse skin incision Pfannenstiel smiley incision at the lower uterine segment immediate clamping of the cord within 30 seconds placental extraction after its spontaneous separation two layers closure of the uterine incision and abdominal closure anatomically in layers All surgical steps were done with adequate hemostasis Furthermore the investigators excluded sections exceeding 90 minutes from skin incision to skin closure
After fetal head extraction participants in both groups were given 5 IU oxytocin Syntocinon Novartis Basel Switzerland as intravenous bolus and continued on infusion of 10 IU oxytocin in 500 mL of Ringer lactate at a rate of 125 mLhour
For all women in group A the surgeon placed two intrauterine misoprostol tablets Misotac 200microgram Sigma Ph Egypt at the fundus after placental delivery and swabbing the cavity followed by suturing the first layer of the uterus while women in group B were given two sublingual misoprostol tablets Misotac 200 microgram Sigma Ph Egypt after placental delivery
The amount of blood loss was determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery The estimated total blood loss during cesarean section was measured after adding the volume of blood in the suction bottle to the soaked surgical towels weighting method then added to the amount of blood lost after section calculated by using blood collection drape Moreover hemoglobin HB level and hematocrit value were repeated 24 hours postpartum The patient vitals were observed and recorded intraoperatively and postoperatively
All participants were subjected to Comprehensive history taking including obstetric medical and surgical history
General examination excluding the presence of any abnormalities Systematic obstetrical examinations A transabdominal ultrasound to confirm the diagnosis and evaluation of fetal condition
A blood sample collected for complete blood counting coagulation studies liver and kidney function tests
All women were subjected to elective lower segment cesarean section by the same team under spinal anesthesia and antibiotic prophylaxis according hospital protocol
Women were divided into two equal groups
Group A 96 women receiving 400 mcg intrauterine misoprostol IV oxytocin Group B 96 women receiving 400 mcg sublingual misoprostol IV oxytocin Both groups were subjected to the same preparation All cesarean deliveries were performed by a senior obstetrics and gynecology resident and the elective sections were performed at 39th weeks gestation adopting the following operative steps transverse skin incision Pfannenstiel smiley incision at the lower uterine segment immediate clamping of the cord within 30 seconds placental extraction after its spontaneous separation two layers closure of the uterine incision and abdominal closure anatomically in layers All surgical steps were done with adequate hemostasis Furthermore the investigators excluded sections exceeding 90 minutes from skin incision to skin closure
After fetal head extraction participants in both groups were given 5 IU oxytocin Syntocinon Novartis Basel Switzerland as intravenous bolus and continued on infusion of 10 IU oxytocin in 500 mL of Ringer lactate at a rate of 125 mLhour
For all women in group A the surgeon placed two intrauterine misoprostol tablets Misotac 200microgram Sigma Ph Egypt at the fundus after placental delivery and swabbing the cavity followed by suturing the first layer of the uterus while women in group B were given two sublingual misoprostol tablets Misotac 200 microgram Sigma Ph Egypt after placental delivery
The amount of blood loss was determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery The estimated total blood loss during cesarean section was measured after adding the volume of blood in the suction bottle to the soaked surgical towels weighting method then added to the amount of blood lost after section calculated by using blood collection drape Moreover hemoglobin HB level and hematocrit value were repeated 24 hours postpartum The patient vitals were observed and recorded intraoperatively and postoperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None