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

Hemorrhage, Postpartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03723031
• Other study ID #: 1121980
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: moutaz elsherbini, MD
• Phone: (+2)01001588300
• Email: mizosherbini[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: May 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage, Postpartum
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine - Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimated blood loss during and after CS	EBL= EBV x { (Preoperative hematocrit - Postoperative hematocrit) ÷ Postoperative hematocrit} Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).	within 12 hours after delivery
Secondary	estimated blood loss during CS	The 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).	within the CS procedure
Secondary	Use of additional ecbolics denoting uterine atony	additional 5 IU intravenous bolus oxytocin and 1mL [0.2 mg] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively)	within CS procedure
Secondary	The occurrence of any maternal side effects (in both groups)	shivering, pyrexia >38C0, headache, nausea, vomiting with or without the need for antiemetic drugs	within 24 hours after the CS procedure
Secondary	The occurrence of any fetal side effects (rectal group only)	APGAR at 1 and 5 minutes, NICU admission and neonatal death	within 24 hours after the CS procedure