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

Primary Purpose

Misoprostol Allergy

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol 200mcg Tab
Misoprostol Pill
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Misoprostol Allergy focused on measuring misoprostol, cesarean section, postpartum hemorrhage

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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).

Sites / Locations

  • faculty of medicine, Kasr el ainy hospital, Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

preop

postop

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Estimation of Intraoperative and postoperative blood loss.
calculate total blood loss in guaze and suction bottle

Secondary Outcome Measures

Need of extra utero-tonic drugs
use of more uterotonic drugs as oxytocin and ergometrin
Incidence of postpartum hemorrhage.
blood loss more than 1000 ml
The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache.
occurance of side effect within 24 hours postoperative

Full Information

First Posted
June 24, 2023
Last Updated
August 19, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05928871
Brief Title
Pre Versus Post-operative Misoprostol in Reducing Blood Loss After Cesarean Section
Official Title
The Effect of Pre-operative Versus Post-operative Misoprostol in Reducing Blood Loss During and After Elective Cesarean Section.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
History taking: Verbal consent. Detailed clinical history. Personal history: Name, Age, Parity, Occupation, Residency and Special habits. - Present history: History of onset, course and duration of vaginal bleeding or bloody vaginal discharge, presence of uterine contraction, PROM, IUGR or any indication for cesarean section. - Obstetric history: History of previous preterm labor, previous abortion, previous full term deliveries, RH incompatibility, mode of delivery and fetal outcome. - Menstrual history: For estimation of gestational age using Naegele's rule, provided that she had regular cycles for the last three months before she got pregnant and was not taking contraceptive pills during this period and she was sure of her dates. Term pregnancy defined as delivery between 37 and 42 weeks of gestation. Gestational age was assessed from the menstrual history and confirmed by measurement of fetal crown-rump length at a first-trimester scan. - Past history: History of medical disorders, drug therapy or allergy or history of intake of other tocolytic drugs. - Family history : For any similar condition Examination Full clinical examination (pulse, temperature and the blood pressure). General examination including blood pressure, heart rate, body temperature, body mass index, head& neck examination, Bilateral lower limb examination, chest, heart and abdominal examination for fundal level. Local clinical examination; assessment of maternal health, obstetric abdominal examination for: fundal level, fetal presentation, estimating fetal weight and scars of previous operations, uterine contraction if present, auscultation of FHR. Vaginal examination will be done to detect condition of cervix (dilatation and effacement). Routine antenatal investigations (Rh, CBC, HTC, Hb, Coagulation profile, fasting and postprandial blood sugar and complete urine analysis). Ultrasonography examination : to assess the following data: Gestational age Fetal viability Fetal presentation and EFW. Exclusion of any fetal congenital anomalies. To ensure that the all inclusion criteria are present. Check amniotic fluid index. Intervention: Cesarean section will be done by a senior registrar who performed at least 300 cesarean sections before the start of the study. All CS will be performed using spinal anesthesia, the abdomen is entered by Pfannenstiel abdominal incision. After induction of anesthesia,patients assigned to group 1 will receive rectal misoprostol immediately after urinary catheterization and before skin incision. Participants are assigned to group 2 will receive 600μg rectal misoprostol immediately after skin closure. all women will be received 5IU of oxytocin by slow intravenous after cord clamping (British Medical, Royal Pharmaceutical society of Great British, 2011). Sterilization and toweling of the patient then the standard technique of trans-peritoneal lower segment cesarean will be adopted.The placenta will be removed by cord traction and uterinecompression. The uterus will be exteriorized and compressed duringclosure which will be achieved by continuous unlocked sutures in 2 layers using Ethicon Vicryl 0 suture. The peritoneum and muscle is closed by Vicryl 0 suture and The sheath is closed by Vicryl 1, and the skin is closed by subcutical suture using proline double zero suture in both groups. Estimation of blood loss was started after skin incision. The linen towels will be weighted in (mg) with its cover before and after the operation using a highly accurate digital balance and the difference in weight between dry and soaked linen towels will be calculated. Blood loss during the operation will be calculated as follows: Volume of the contents of the suction bottle (ml) (A). Difference in weight of linen towels (gm) (B) (weight of soaked linen towels (gm) - weight of dry linen towels (gm)). Amniotic fluid volume (ml) (C). So blood loss during operation (ml) = (A + B) - C (Lapaire et al., 2006). Allowable blood loss was calculated for all women according to the underlying law . ABL= EBV x (Hi - Hf) Hi Hi = initial Hct Hf = final lowest acceptable Hct Estimated Blood Volume (EBV) EBV = weight (kg) X average blood volume (65-75 ml/kg ) A trained nurse will be responsible for collection of wound dressing placed in vulval area during the first 24 hours after surgery and the difference in weight will be calculated. The overall blood loss will be calculated. Changes in hemoglobin concentration and hematocrit value will be measured 24 hours after the cesarean section. The need for additional utero-tonic drugs will be given according to the attendant consultant decision or a blood loss more than 1000ml intra operative. Operative time, need for blood transfusion and side effects of study drug e.g. nausea, vomiting, diarrhea will be recorded. All the patients will receive non-steroidal anti-inflammatory preparation in the form of (Rheumarene®) 75mg IM (one ampoule) immediately postoperative then one ampoule 12 hours postoperative and the need for extra analgesics will be recorded & the degree of postoperative pain will be estimated using visual analogue scale will be done (3 hours and 24 hours) after the operation. The Apgar score of the fetus at 1 and 5 minutes, the need for neonatal intensive care unit (NICU) admission and neonatal death will be assessed in the two groups. Data were collected and tabulated and statistically analyzed by IBM computer using the Statistical Package for the Social Sciences (SPSS version 15). Chi-square test was used to compare qualitative variables between groups and Fisher exact test was used instead of Chisquare test when the expected cell count is less than 5. Student t-test was used to compare the quantitative variables in parametricdata. p value <0.05 was set significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Misoprostol Allergy
Keywords
misoprostol, cesarean section, postpartum hemorrhage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preop
Arm Type
Active Comparator
Arm Description
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)
Arm Title
postop
Arm Type
Active Comparator
Arm Description
60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation).
Intervention Type
Drug
Intervention Name(s)
Misoprostol 200mcg Tab
Other Intervention Name(s)
Misotac
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Misoprostol Pill
Other Intervention Name(s)
misotac
Intervention Description
60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation).
Primary Outcome Measure Information:
Title
Estimation of Intraoperative and postoperative blood loss.
Description
calculate total blood loss in guaze and suction bottle
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Need of extra utero-tonic drugs
Description
use of more uterotonic drugs as oxytocin and ergometrin
Time Frame
24 hours
Title
Incidence of postpartum hemorrhage.
Description
blood loss more than 1000 ml
Time Frame
24 hours
Title
The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache.
Description
occurance of side effect within 24 hours postoperative
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients will be recruited in this study those attending labor ward at kasr el ainy hospital for elective cesarean section
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
waleed M El-khayat, MD
Phone
01005135542
Email
waleed_elkhyat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Taymour, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine, Kasr el ainy hospital, Cairo university
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad A Taymour, MD
Phone
01555761995
Email
Mohammadtaymour@gmail.com
First Name & Middle Initial & Last Name & Degree
Waleed M Elkhyat
Phone
01005135542
Email
Waleed_elkhyat@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Mousa H, Alfirevic Z. (2009): Treatment for primary postpartum hemorrhage (Cochrane review). Chichcster (UK): John Wiley&Sons Ltd. The Cochrane Library; Issue4
Results Reference
background
PubMed Identifier
11821273
Citation
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.
Results Reference
background
Citation
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.
Results Reference
result
PubMed Identifier
17012482
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
British Medical Association, Royal Pharmaceutical Society of Great Britain (2011): British National Formulary. Cesarean section: an entire guideline. 2011. London.
Results Reference
result
PubMed Identifier
17027730
Citation
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.
Results Reference
result
PubMed Identifier
12738159
Citation
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.
Results Reference
result
PubMed Identifier
16309682
Citation
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.
Results Reference
result
PubMed Identifier
16934269
Citation
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.
Results Reference
result
PubMed Identifier
16108235
Citation
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.
Results Reference
result
PubMed Identifier
23728648
Citation
Mathai M, Hofmeyr GJ, Mathai NE. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2013 May 31;(5):CD004453. doi: 10.1002/14651858.CD004453.pub3.
Results Reference
result

Learn more about this trial

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

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