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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03723031
Other study ID # 1121980
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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