Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
History taking:
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
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.
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 )
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preop | Active Comparator | 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) |
|
| postop | Active Comparator | 60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol 200mcg Tab | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of Intraoperative and postoperative blood loss. | calculate total blood loss in guaze and suction bottle | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Need of extra utero-tonic drugs | use of more uterotonic drugs as oxytocin and ergometrin | 24 hours |
| Incidence of postpartum hemorrhage. | blood loss more than 1000 ml |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients will be recruited in this study those attending labor ward at kasr el ainy hospital for elective cesarean section
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| waleed M El-khayat, MD | Contact | 01005135542 | waleed_elkhyat@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed A Taymour, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine, Kasr el ainy hospital, Cairo university | Recruiting | Cairo | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Mousa H, Alfirevic Z. (2009): Treatment for primary postpartum hemorrhage (Cochrane review). Chichcster (UK): John Wiley&Sons Ltd. The Cochrane Library; Issue4 | ||
| 11821273 | Background | 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. | |
| Result | 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. | ||
| 17012482 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Misoprostol Pill | Drug | 60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation). |
|
|
| 24 hours |
| The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache. | occurance of side effect within 24 hours postoperative | 24 hours |
| Result |
| 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. |
| Result | 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. |
| Result | British Medical Association, Royal Pharmaceutical Society of Great Britain (2011): British National Formulary. Cesarean section: an entire guideline. 2011. London. |
| 17027730 | Result | 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. |
| 12738159 | Result | 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. |
| 16309682 | Result | 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. |
| 16934269 | Result | 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. |
| 16108235 | Result | 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. |
| 23728648 | Result | Mathai M, Hofmeyr GJ, Mathai NE. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD004453. doi: 10.1002/14651858.CD004453.pub3. |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |