Clinical trial NCT03140033: Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery
Official title: Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemorrhage Postpartum
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 158
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial

Detailed description: This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancies
* women booked for elective C.S
* full term pregnancies
* primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )

Exclusion Criteria:

* blood disorders
* multiple pregnancy
* placenta previa
* polyhydramnios
* marked maternal anemia
* contraindications to prostaglandin e.g history of asthma , allergy to misoprostol
* previous 2 or more C.S

Primary outcomes:
measure: Blood loss during cesarean sections
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Vaginal bleeding
timeFrame: through study completion, an average of 1 year
measure: Change in blood pressure and pulse
timeFrame: through study completion, an average of 1 year
measure: Blood loss after 24 hr.
timeFrame: through study completion, an average of 1 year
measure: Need for additional uterotonic agent
timeFrame: through study completion, an average of 1 year
measure: Need for blood transfusion
timeFrame: through study completion, an average of 1 year
measure: Need for surgical measures to stop bleeding
timeFrame: through study completion, an average of 1 year
measure: Side effects of misoprostol
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams maternity hospital
Study officials:
affiliation: Ain Shams University-Maternity Hospital
name: Amr H YEHIA, MD,MRCOG
role: STUDY_DIRECTOR
References: