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Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During Cesarean Section

The Efficacy and Safety of Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During and After Cesarean Section

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03723031
Enrollment
98
Registered
2018-10-29
Start date
2018-11-15
Completion date
2020-05-15
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage, Postpartum

Keywords

hemorrhage, misopristol, Cesarean section

Brief summary

98 pregnant women attending for CS will be randomized into 2 groups. Rectal misopristol group who will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion and intrauterine misopristol group will receive 400 microgram misoprostol intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta. The estimated blood loss for each patient will be measured and data of both groups will be compared.

Detailed description

The study we will include (98) pregnant women attending for cesarean delivery in the Kasr Elaini hospital (faculty of medicine - Cairo university).After signing informed written consent, all participants will be subjected to: Full medical history(including full obstetric history and current pregnancy history and the 1st day of last menstrual period), thorough clinical examination (general and full obstetric examination), obstetric ultrasonography (to confirm gestational age and the eligibility of the current pregnancy to participate in the study) and preoperative laboratory tests (including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests). Group allocation: On the day of the cesarean delivery, participants will be randomly assigned in a 1:1 ratio into two groups; group A (Rectal misoprostol) and group B (Intrauterine misoprostol). Randomization will be performed using computer-generated random numbers and only the participants will be masked to the group allocation. Group A (Rectal misoprostol - n=49) will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion while group B (Intrauterine misoprostol n=49) will receive 400 microgram misoprostol (cytotec, Pfizer, G.D. Searle LLC) inserted intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta. Following the delivery of the baby, patients in both groups will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h). All cesarean sections will be done under spinal anesthesia by the following operative steps: pfannenstiel incision, transverse lower uterine segment incision, immediate cord clamping (\< 30 seconds) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps). The number and the difference of weight of operative towels (before and after CS) and amount of blood in suction unit will be recorded. The estimated blood loss for each patient will be measured and data of both groups will be compared. In group A, the time interval between rectal misoprostol insertion and fetal delivery will be recorded together with the neonatal outcome (APGAR at 1 and 5 minutes, NICU admission and neonatal death). Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 12 hours after delivery. All patients will be followed up for 24 hours following the delivery as regard occurrence of primary postpartum hemorrhage, the need for blood transfusion, misoprostol-related side effects in the first 6 hours (i.e. shivering, pyrexia more than 38 degree Centigrate, headache, nausea, vomiting with or without the need for anti-emetic drugs).

Interventions

DRUGMisoprostol

400 microgram (2 tablets) misoprostol ( cytotec, Pfizer, G.D. Searle LLC) inserted rectally (before CS) in rectal group or intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta in intrauterine group.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women candidate for CS. * Full term singleton living pregnancies (\> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan). * Spinal or epidural anesthesia for the CS.

Exclusion criteria

* Maternal Anemia (hemoglobin \<9 g%) * Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, or coagulopathies). * Fetal anomalies or IUGR (estimated fetal weight below the 5th centile) * Risk of obstetric hemorrhage (e.g. peripartum hemorrhage, abnormal placentation, previous history of uterine atony or postpartum hemorrhage). * Women attending for emergency CS. * More than 2 previous CS procedures. * Prolonged procedure (more than 2 hours from skin incision to skin closure). * History of prostaglandin allergy.

Design outcomes

Primary

MeasureTime frameDescription
estimated blood loss during and after CSwithin 12 hours after deliveryEBL= EBV x { (Preoperative hematocrit - Postoperative hematocrit) ÷ Postoperative hematocrit} Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).

Secondary

MeasureTime frameDescription
The occurrence of any maternal side effects (in both groups)within 24 hours after the CS procedureshivering, pyrexia \>38C0, headache, nausea, vomiting with or without the need for antiemetic drugs
The occurrence of any fetal side effects (rectal group only)within 24 hours after the CS procedureAPGAR at 1 and 5 minutes, NICU admission and neonatal death
estimated blood loss during CSwithin the CS procedureThe number of operative towels used - The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss).
Use of additional ecbolics denoting uterine atonywithin CS procedureadditional 5 IU intravenous bolus oxytocin and 1mL \[0.2 mg\] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively)

Countries

Egypt

Contacts

Primary Contactmoutaz elsherbini, MD
mizosherbini@yahoo.com(+2)01001588300
Backup ContactMirna mohamed awad, MSc
mirnaawad91.ma@gmail.com(+2)01001401172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026