Prevention of Primary Postpartum Haemorrhage

NCT ID: NCT04724187

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2021-08-30

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.

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.

Conditions

Primary; Post Partum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intrauterine misoprostol and oxytocin

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

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

it is prostaglandin E1 .

Oxytocin

Intervention Type: DRUG

it stimulates uterine contractions

oxytocin

only oxytocin will stimulate uterine contraction

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

it stimulates uterine contractions

Interventions

Misoprostol

it is prostaglandin E1 .

Intervention Type: DRUG

Oxytocin

it stimulates uterine contractions

Intervention Type: DRUG

Other Intervention Names

Arthotec; syntocinon

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Islamabad Medical and Dental College

OTHER

Sponsor Role: lead

Responsible Party

Afnan Rizwan

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Islamabad medical and Dental College

Islamabad, Federal, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Facility Contacts

Afnan Rizwan, Fellowship

Role: primary

afnan.rizwan@imdcollege.edu.pk

+92 3329306328

Naila I Hadi, PhD

Role: backup

naila.irum@imdcollege.edu.pk

+92 3009299512

Other Identifiers

ARizwan

Identifier Type: -

Identifier Source: org_study_id