Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

• Sponsor: Ain Shams Maternity Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03140033
• Collaborator: (none)
• Enrollment: 158
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage Postpartum	Drug: Misoprostol Oral Tablet; Drug: Ranitidine Oral Tablet	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study
• Actual Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: May 1, 2017
• Anticipated Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misoprostol oral tablets 79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping	Drug: Misoprostol Oral Tablet; at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually; Other Names: Misotac
Placebo Comparator: Ranitidine oral tablets 79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping	Drug: Ranitidine Oral Tablet; at cord clamping the patient will recieve ranitidine sublingually; Other Names: Ranitak

Outcome Measures

Primary Outcome Measures

1. Blood loss during cesarean sections [through study completion, an average of 1 year]

   Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta

Secondary Outcome Measures

1. Vaginal bleeding [through study completion, an average of 1 year]

   Calculation of the amount of vaginal bleeding according to the number of soaked pads used after cesarea section for the 1st 6 hrs. Each soaked pad equal 50 cc

2. Change in blood pressure and pulse [through study completion, an average of 1 year]

   Change in blood pressure and pulse before and after the cesarean section

3. Blood loss after 24 hr. [through study completion, an average of 1 year]

   The allowable blood loss (ABL) =[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) ] / HI ( initial hematocrit)

4. Need for additional uterotonic agent [through study completion, an average of 1 year]

   Need for additional uterotonic agent e.g oxytocin - methyl ergotamine

5. Need for blood transfusion [through study completion, an average of 1 year]

   number of patients receiving blood transfusion

6. Need for surgical measures to stop bleeding [through study completion, an average of 1 year]

   Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy

7. Side effects of misoprostol [through study completion, an average of 1 year]

   Nausea, Vomiting or Diarrhea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain shams maternity hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams Maternity Hospital

Investigators

• Study Director: Amr H YEHIA, MD,MRCOG, Ain Shams University-Maternity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Fathy, Resident of obstetrics and gynecology, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT03140033
• Other Study ID Numbers: MFathy
• First Posted: May 4, 2017
• Last Update Posted: May 4, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Postpartum Hemorrhage; Hemorrhage; Misoprostol; Ranitidine; Ranitidine bismuth citrate

Study Results

No Results Posted as of May 4, 2017