Prevention of Primary Postpartum Haemorrhage

NCT04724187 | Unknown Phase 2 DMC

• 1 other identifier: ARizwan
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum hemorrhage, is one of the most deadly complication of pregnancy worldwide and major cause of maternal mortality especially in third world countries .1 PPH affects about 5% of all women giving birth around the world 2 .Primary PPH is defined as ≥500 mL blood loss after vaginal delivery or ≥1000 mL after CS delivery within 24 hours after birth1 . Globally, almost one quarter of all maternal deaths are linked with PPH 2. Due to the high prevalence of anemia among pregnant women in low-resource settings, the outcome of PPH is often deteriorated, resulting in damaging health consequences 3. Roughly in 70% of cases of primary pph are due to uterine atony11. Uterine atony is due to loss of contraction and retraction of myometrial muscle fibers can lead to severe hemorrhage and shock. There are several reasons behind uterine atony including maternal anemia, fatigue due to prolong labour and rapid forceful labour. Blood loss is double in caesarean section due to use of increased anesthetic agents4. According to WHO use of oxytocin (10 IU, IM /IV) is recommended for prevention of PPH for all births2. Despite its effectiveness, 10-40% of cases need additional uterotonics to ensure good uterine contraction.5 After oxytocin , Misoprostol is increasingly known as a potential treatment option for PPH 5 .Misoprostol is easily available , rapid acting , and cost effective with minimal side effects, however in caesarean section owing to the effect of anesthesia limits its use . In recent study conducted at Egypt, oxytocin plus misoprostol (study group) is compared with oxytocin alone (control group). Incident of pph was significantly lower in study group (p=0.018), as in study group (1.33%) than control group (6.67%)8. Misoprostol is an autacoid substance and act better if placed closed to target organ 9. Several routes of misoprostol, with or without oxytocin, and its result on intrapartum and postpartum hemorrhage are described in the literature. The practice of misoprostol by the intrauterine route during caesarean section is under trial.10. Aim of study is to observe the effectiveness of intrauterine misoprostol in addition to oxytocin to minimize the blood loss during caesarean section.

Conditions

Primary; Post Partum Hemorrhage

Keywords

primary,oxytocin,; postpartum haemorrhage; mesoprostol

Outcome Measures

Primary Outcomes (1)

• measurement of haemoglobin level to assess the blood loss

  haemoglobin will be measured preoperatively and postoperatively to minimize the blood loss during cesarean section

  six months

Study Arms (2)

intrauterine misoprostol and oxytocin

EXPERIMENTAL

there will be added effect of misoprostol to stimulate uterine contraction along with oxytocin

Drug: Misoprostol; Drug: Oxytocin

oxytocin

ACTIVE COMPARATOR

only oxytocin will stimulate uterine contraction

Drug: Oxytocin

Interventions

Misoprostol DRUG

it is prostaglandin E1 .

Also known as: Arthotec

intrauterine misoprostol and oxytocin

Oxytocin DRUG

it stimulates uterine contractions

Also known as: syntocinon

intrauterine misoprostol and oxytocin; oxytocin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: reproductive age group 18-40years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. All LSCS including emergency and elective 2. Full term pregnancy \>37 week

You may not qualify if:

• \. All vaginal deliveries 2. Patients with bleeding or clotting disorders 3. Maternal cardiac, renal, hepatic diseases 4. Morbidly adherent placentas 5. Preterm deliveries

Sponsors & Collaborators

• Islamabad Medical and Dental College: lead

Study Sites (1)

Islamabad medical and Dental College

Islamabad, Federal, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Arthotec; Oxytocin

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; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: October 28, 2020
• First Posted: January 26, 2021
• Study Start: February 3, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

PA (1)