Pre Versus Post-operative Misoprostol in Reducing Blood Loss After Cesarean Section

NCT05928871 | Unknown Phase 4

• 1 other identifier: AN2023-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section is the most common performed major surgical interventions among women all over the world.Cesarean section has many serious complications, including primary postpartum hemorrhage (PPH). Postpartum hemorrhage is one of the most serious causes of maternal mortality and morbidity, especially in developing countries, and the number of maternal deaths due to postpartum hemorrhage is estimated to exceed 100,000 maternal deaths each year. The incidence of CS is increasing and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL) . The most successful technique for decreasing PPH is active management of the third stage of labor (AMTSL), requires prophylactic utero-tonic drugs as oxytocin, ergometrine malate and combinations of them , They must be administered by injection. Misoprostol is synthetic prostaglandin (PGE1 analogue), with utero-tonic properties, has been proposed as an alternative strategy for prevention of PPH in settings where oxytocin use is not handy. It has important advantages over oxytocin, including the potential for oral administration and a long shelf life at room temperature.Misoprostol is affordable and widely available, can be easily administered via multiple routes, and has a good safety profile if properly administered and monitored, all of which makes it an alternative treatment option of PPH in developing countries. Investigators were comparing the effect of preoperative and post-operative rectally administrated misoprostol on operative blood loss at cesarean section. Misoprostol has an important effect in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions.

Conditions

Misoprostol Allergy

Keywords

misoprostol; cesarean section; postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• Estimation of Intraoperative and postoperative blood loss.

  calculate total blood loss in guaze and suction bottle

  24 hours

Secondary Outcomes (3)

• Need of extra utero-tonic drugs

  24 hours

• Incidence of postpartum hemorrhage.

  24 hours

• The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache.

  24 hours

Study Arms (2)

preop

ACTIVE COMPARATOR

60 women: will receive preoperative 600 microgram of misoprostol ( 3 tablets ) rectally after spinal anaesthesia and urinary catheterization and postoperative placebo (3 tablets). (as per WHO dose recommendation)

Drug: Misoprostol 200mcg Tab

postop

ACTIVE COMPARATOR

60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation).

Drug: Misoprostol Pill

Interventions

Misoprostol 200mcg Tab DRUG

60 women: will receive preoperative 600 microgram of misoprostol ( 3 tablets ) rectally after spinal anaesthesia and urinary catheterization and postoperative placebo (3 tablets). (as per WHO dose recommendation)

Also known as: Misotac

preop

Misoprostol Pill DRUG

60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation).

Also known as: misotac

postop

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Patients will be recruited in this study those attending labor ward at kasr el ainy hospital for elective cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women booked for elective cesarean section not in active labor
• Scheduled for primary elective caesarian section.
• No contraindications to prostaglandins.
• Have no history of coagulopathy.
• Aged between 18-40 years.
• Full term pregnancies (GA 37 to 42 weeks).
• Singleton pregnancies.
• BMI 20-30 kg/ m2

You may not qualify if:

• Placenta previa.
• Maternal hypertension and Pre-eclampsia. .
• Diabetes mellitus.
• Previous CS and those with active labor.
• Multiple Fibroid uterus .
• Multiple pregnancies.
• Overdistended uterus eg. polyhydramnios
• Previous myomectomy, previous history of PPH .
• Contraindication to spinal anesthesia.
• Blood coagulopathy and bleeding disorder.
• Marked maternal anemia (Preoperative hemoglobin \<9 gm/dl).
• Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
• Extreme of BMI (\<20 or \>30Kg/m2).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, 11562, Egypt

RECRUITING

Related Publications (12)

• Mousa H, Alfirevic Z. (2009): Treatment for primary postpartum hemorrhage (Cochrane review). Chichcster (UK): John Wiley&Sons Ltd. The Cochrane Library; Issue4

  BACKGROUND

• Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. doi: 10.1093/humrep/17.2.332.

  PMID: 11821273 BACKGROUND

• Is the time of administration of misoprostol of value? The uterotonic effect of misoprostol given pre-and post-operative after elective cesarean section. Middle East Fertility Society Journal, 19(1), 8-12.

  RESULT

• American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. doi: 10.1097/00006250-200610000-00046.

  PMID: 17012482 RESULT

• Cunningham F. G., Leveno K. J., Bloom Steven L., Hauth John C., Dwight J. Rouse, Dwight J. Rouse. (2001): William's Obstetrics 23rd Edition ISBN: 0071497013, ISBN-13: 9780071497015, PUB. PUBLISHER: The McGraw-Hill Companies.

  RESULT

• British Medical Association, Royal Pharmaceutical Society of Great Britain (2011): British National Formulary. Cesarean section: an entire guideline. 2011. London.

  RESULT

• Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, Patted SS, Patel A, Edlavitch SA, Hartwell T, Chakraborty H, Moss N. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet. 2006 Oct 7;368(9543):1248-53. doi: 10.1016/S0140-6736(06)69522-6.

  PMID: 17027730 RESULT

• Khan RU, El-Refaey H. Pharmacokinetics and adverse-effect profile of rectally administered misoprostol in the third stage of labor. Obstet Gynecol. 2003 May;101(5 Pt 1):968-74. doi: 10.1016/s0029-7844(03)00174-1.

  PMID: 12738159 RESULT

• Langenbach C. Misoprostol in preventing postpartum hemorrhage: a meta-analysis. Int J Gynaecol Obstet. 2006 Jan;92(1):10-8. doi: 10.1016/j.ijgo.2005.10.001. Epub 2005 Nov 23.

  PMID: 16309682 RESULT

• Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynaecol Obstet. 2006 Oct;95(1):2-7. doi: 10.1016/j.ijgo.2006.05.031. Epub 2006 Aug 23.

  PMID: 16934269 RESULT

• Magann EF, Evans S, Hutchinson M, Collins R, Lanneau G, Morrison JC. Postpartum hemorrhage after cesarean delivery: an analysis of risk factors. South Med J. 2005 Jul;98(7):681-5. doi: 10.1097/01.SMJ.0000163309.53317.B8.

  PMID: 16108235 RESULT

• Mathai M, Hofmeyr GJ, Mathai NE. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD004453. doi: 10.1002/14651858.CD004453.pub3.

  PMID: 23728648 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mohammed A Taymour, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

waleed M El-khayat, MD

CONTACT

01005135542; waleed_elkhyat@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 3, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)