Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections

NCT06364098 | Completed Phase 1

• 1 other identifier: prevention of PPH
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Study design: A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University. Population of study: 192 pregnant women at the age range from 20 to 35 years, with BMI \< 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age \>39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level \<9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• The amount of blood loss

  determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery

  6 hours

Secondary Outcomes (2)

• Changes in hematocrit values in both groups after delivery

  24 hours

• Changes in Hemoglobin level measured by gm/dl in both groups after delivery

  24 hours

Other Outcomes (1)

• Incidence of side effects of study medications

  24 hours

Study Arms (2)

intrauterine misoprostol group (Group A)

EXPERIMENTAL

96 women receiving 400 mcg intrauterine misoprostol + IV oxytocin.

Drug: Misoprostol

sublingual misoprostol group (Group B)

ACTIVE COMPARATOR

: 96 women receiving 400 mcg sublingual misoprostol + IV oxytocin.

Drug: Misoprostol

Interventions

Misoprostol DRUG

400 microgram of misoprostol given either sublingually or intrauterine during CS after placental removal together with IV oxytocin infusion

intrauterine misoprostol group (Group A); sublingual misoprostol group (Group B)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20-35 years.
• BMI \< 30kg/m2.
• Singleton pregnancy.
• Full term pregnancies (recruiting from 37 weeks of gestation).
• Elective cesarean section (previous one or two cesarean section).

You may not qualify if:

• Active labour before 39 weeks.
• Uterine over distension as due to multiple pregnancies or polyhydramnios.
• Multipara \[parity ≥3\].
• Pregnancy with obstetric haemorrhage such as placenta Previa, placental abruption or vasa Previa.
• Moderate to severe anemia with HB \<9mg/dL.
• Pregnancy with coagulopathy, thrombocytopenia or blood dyscrasias.
• Women with uterine fibroids.
• Medically complicated pregnancy (pregnancy induced hypertension, cardiovascular, DM, hepatic, or renal disorders).
• Women with any contraindication for the use of misoprostol or oxytocin as a history of prostaglandin allergy and current medication which could cause severe drug interaction to prostaglandins such as topical dinoprostone, magnesium-containing antacids or quinapril.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Kasr Alainy

Cairo, Al Manyal, 11956, Egypt

Location

Related Publications (6)

• Gallos I, Williams H, Price M, Pickering K, Merriel A, Tobias A, Lissauer D, Gee H, Tuncalp O, Gyte G, Moorthy V, Roberts T, Deeks J, Hofmeyr J, Gulmezoglu M, Coomarasamy A. Uterotonic drugs to prevent postpartum haemorrhage: a network meta-analysis. Health Technol Assess. 2019 Feb;23(9):1-356. doi: 10.3310/hta23090.

  PMID: 30821683 BACKGROUND

• Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.

  PMID: 29693726 BACKGROUND

• Escobar MF, Nassar AH, Theron G, Barnea ER, Nicholson W, Ramasauskaite D, Lloyd I, Chandraharan E, Miller S, Burke T, Ossanan G, Andres Carvajal J, Ramos I, Hincapie MA, Loaiza S, Nasner D; FIGO Safe Motherhood and Newborn Health Committee. FIGO recommendations on the management of postpartum hemorrhage 2022. Int J Gynaecol Obstet. 2022 Mar;157 Suppl 1(Suppl 1):3-50. doi: 10.1002/ijgo.14116. No abstract available.

  PMID: 35297039 BACKGROUND

• Awoleke JO, Adeyanju BT, Adeniyi A, Aduloju OP, Olofinbiyi BA. Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community. J Obstet Gynaecol India. 2020 Dec;70(6):462-470. doi: 10.1007/s13224-020-01338-0. Epub 2020 Jun 29.

  PMID: 33417650 BACKGROUND

• Bagheri FZ, Azadehrah M, Shabankhani B, Nasiri Formi E, Akbari H. Rectal vs. sublingual misoprostol in cesarean section: Three-arm, randomized clinical trial. Caspian J Intern Med. 2022 Winter;13(1):84-89. doi: 10.22088/cjim.13.1.84.

  PMID: 35178212 BACKGROUND

• Atef A, Shehata HSEAM, Bassiouny YA, Al-Inany HG. Comparative study between the roles of intrauterine misoprostol versus the sublingual route for prevention of postpartum blood loss in elective cesarean sections: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Oct 29;24(1):710. doi: 10.1186/s12884-024-06889-y.

  PMID: 39472831 DERIVED

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 15, 2024
• Study Start: January 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

EG (1)