Prevention of Primary Postpartum Haemorrhage

Comparison of Intrauterine Misoprostol Plus Intravenous Oxytocin Versus Intravenous Oxytocin Alone for Prevention of Primary Postpartum Haemorrhage in Population of Bhara Kahu.

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.

Study Overview

• Status: Unknown
• Conditions: Post Partum Hemorrhage; Primary
• Intervention / Treatment: Drug: Misoprostol; Drug: Oxytocin

Detailed Description

Data will be collected from all the patients full filling inclusion criteria on especially designed Performa after informed consent of patient, demographic data will be collected on that preform Patients will be randomized and divide in to two groups group A ( study group ) and group B (controls) , patients under group A will be given 600 microgram misoprostol through intra uterine route during lower segment caesarean section after delivery of placenta in addition to oxytocin 10IU IV and Group B (control) only oxytocin 10IU IV will be given according to WHO protocol .In both groups pre-operative hemoglobin done within 24 hours before the surgery will be recorded and compared with post-operative hemoglobin estimated by blood sample taken 48 hours after the surgery .Mean blood loss during caesarean section will be documented by counting the number of towels , need of additional drugs (repeat oxytocin, tranexamic acid, additional misoprostol) ,time of contractility of uterus, blood transfusion, side effects of misoprostol that is fever, shivering, nausea, vomiting will be recorded 24 hours postoperative period.

All the collected data will be entered and analyzed by SPSS v. 21. Mean and standard deviation will be calculated for quantitative variables like age, gestational age, BMI, pre and post Hb, and blood loss during caesarean section. Frequencies along with percentages will be presented for qualitative variables like need of additional drugs, and side effects of misoprostol (fever, shivering, nausea, vomiting). Paired sample t-test will be used to compare pre and post Hb levels of both groups. Independent sample t-test will be applied to compare post Hb level, blood loss between both groups. Chi-square test will be employed to compare side effects (fever, shivering, nausea, vomiting) between both groups. P-value ≤ 0.05 will be taken as significant.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Recruiting
      • Islamabad Medical and Dental College
      • Contact: Afnan Rizwan, Fellowship; Phone Number: +92 3329306328; Email: afnan.rizwan@imdcollege.edu.pk
      • Contact: Naila I Hadi, PhD; Phone Number: +92 3009299512; Email: naila.irum@imdcollege.edu.pk
      • Sub-Investigator: Kinza Alam, Fellowship

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intrauterine misoprostol and oxytocin; there will be added effect of misoprostol to stimulate uterine contraction along with oxytocin	Drug: Misoprostol; it is prostaglandin E1 .; Other Names: Arthotec; Drug: Oxytocin; it stimulates uterine contractions; Other Names: syntocinon
Active Comparator: oxytocin; only oxytocin will stimulate uterine contraction	Drug: Oxytocin; it stimulates uterine contractions; Other Names: syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Islamabad Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: postpartum haemorrhage; mesoprostol; primary,oxytocin,
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: ARizwan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No