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Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03140033
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Fathy, Ain Shams Maternity Hospital

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 Type : Interventional  (Clinical Trial)
Estimated 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 : July 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Ranitak




Primary Outcome Measures :
  1. Blood loss during cesarean sections [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: through study completion, an average of 1 year ]
    Need for additional uterotonic agent e.g oxytocin - methyl ergotamine

  5. Need for blood transfusion [ Time Frame: through study completion, an average of 1 year ]
    number of patients receiving blood transfusion

  6. Need for surgical measures to stop bleeding [ Time Frame: 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 [ Time Frame: through study completion, an average of 1 year ]
    Nausea, Vomiting or Diarrhea



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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140033


Contacts
Contact: Mohamed H Fathy, M.B.B.Ch 00201099984100 Mohamedfathy31085@gmail.com
Contact: Amr YEHIA, MD,MRCOG 00201227900014 am_helmy77@hotmail.com

Locations
Egypt
Ain shams maternity hospital Recruiting
Cairo, Egypt
Contact: Mohamed Fathy, M.B.B.Ch    00201099984100    Mohamedfathy31085@gmail.com   
Contact: AMR Helmy, MD.MRCOG    00201227900014    am_helmy77@hotmail.com   
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
Study Director: Amr H YEHIA, MD,MRCOG Ain Shams University-Maternity Hospital

Responsible Party: Mohamed Fathy, Resident of obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03140033     History of Changes
Other Study ID Numbers: MFathy
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Hemorrhage
Postpartum Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Misoprostol
Ranitidine
Ranitidine bismuth citrate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action