Skip to main content
Top
Published in: Archives of Gynecology and Obstetrics 6/2018

01-12-2018 | Maternal-Fetal Medicine

RETRACTED ARTICLE: Rectal vs. sublingual misoprostol before cesarean section: double-blind, three-arm, randomized clinical trial

Authors: Mohamed S. Sweed, Mourad M. El-Saied, Amgad E. Abou-Gamrah, Haitham A. El-Sabaa, Mohamed M. Abdel-Hamid, Hossam Hemeda, Ahmed M. Mansour, Mohamed E. Shawky, Medhat A. El-Sayed, Radwa M. Mohamed

Published in: Archives of Gynecology and Obstetrics | Issue 6/2018

Login to get access

Abstract

Purpose

The commonest surgical procedure for women is cesarean delivery. Postpartum hemorrhage and intra-operative blood during cesarean delivery is a major concern to all obstetricians. This study was conducted to assess the efficacy of the adjuvant use of misoprostol and oxytocin in decreasing intra-operative blood loss in cesarean delivery.

Methods

This was a double-blinded randomized clinical trial including 636 term pregnant woman scheduled for cesarean section at Ain Shams University Maternity Hospital, Cairo, Egypt, between February 2013 and February 2014. Participants received either 400-μg misoprostol rectally or sublingually or placebo before cesarean section together with 5-IU oxytocin IV. The main outcome measure was intra-operative blood loss. Difference between the three groups was analyzed using one-way ANOVA test (for numeric variables) and Chi-square test (for categorical variables). P < 0.05 was considered statistically significant.

Results

Intra-operative blood loss was higher in patients who did not receive misoprostol (Placebo Group) (295–1075 ml, 641.7 ± 135.7) than those who received it, regardless the route of administration, rectal (135–830 ml, 457.5 ± 140.7; P < 0.001), and sublingual (135–680 ml, 357.8 ± 129.7; P < 0.001). In addition, sublingual route was associated with significantly lower estimated intra-operative blood loss compared to rectal administration (P < 0.001).

Conclusions

Misoprostol with oxytocin is an effective drug-combination for decreasing intra-operative blood loss during cesarian section with clinical superiority to sublingual over rectal route.
Literature
1.
go back to reference Ananth CV, Vintzileos AM (2011) Trends in cesarean delivery at preterm gestation and association with perinatal mortality. Am J Obstet Gynecol 204:505–508CrossRef Ananth CV, Vintzileos AM (2011) Trends in cesarean delivery at preterm gestation and association with perinatal mortality. Am J Obstet Gynecol 204:505–508CrossRef
2.
go back to reference Getahun D, Strickland D, Lawrence JM, Fassett MJ, Koebnick C, Jacobsen SJ (2009) Racial and ethnic disparities in the trends in primary cesarean delivery based on indications. Am J Obstet Gynecol 201:422–427CrossRef Getahun D, Strickland D, Lawrence JM, Fassett MJ, Koebnick C, Jacobsen SJ (2009) Racial and ethnic disparities in the trends in primary cesarean delivery based on indications. Am J Obstet Gynecol 201:422–427CrossRef
4.
go back to reference ACOG Practice Bulletin (2006) Clinical management guidelines for obstetrician-gynecologists number 76, October 2006: postpartum hemorrhage. Obstet Gynecol 108:1039–1047 ACOG Practice Bulletin (2006) Clinical management guidelines for obstetrician-gynecologists number 76, October 2006: postpartum hemorrhage. Obstet Gynecol 108:1039–1047
5.
go back to reference Langenbach C (2006) Misoprostol in preventing postpartum hemorrhage: a meta-analysis. Int J Gynecol Obstet 92:10–18CrossRef Langenbach C (2006) Misoprostol in preventing postpartum hemorrhage: a meta-analysis. Int J Gynecol Obstet 92:10–18CrossRef
6.
go back to reference Munn MB, Owen J, Vincent R, Wakefield M, Chestnut DH, Hauth JC (2001) Comparison of two oxytocin regimens to prevent uterine atony at cesarean delivery: a randomized controlled trial. Obstet Gynecol 98:386–390PubMed Munn MB, Owen J, Vincent R, Wakefield M, Chestnut DH, Hauth JC (2001) Comparison of two oxytocin regimens to prevent uterine atony at cesarean delivery: a randomized controlled trial. Obstet Gynecol 98:386–390PubMed
7.
go back to reference World Health Organization (2012) WHO recommendations for the prevention and treatment of postpartum hemorrhage. World Health Organization, Geneva World Health Organization (2012) WHO recommendations for the prevention and treatment of postpartum hemorrhage. World Health Organization, Geneva
8.
go back to reference Gulmezoglu AM, Forna F, Villar J, Hofmeyr GJ (2007) Prostaglandins for preventing postpartum haemorrhage. Cochrane Database Syst Rev 8(3):494 Gulmezoglu AM, Forna F, Villar J, Hofmeyr GJ (2007) Prostaglandins for preventing postpartum haemorrhage. Cochrane Database Syst Rev 8(3):494
9.
go back to reference Conde-Agudelo A, Nieto A, Rosas-Bermudez A, Romero R (2013) Misoprostol to reduce intraoperative and postoperative hemorrhage during cesarean delivery: a systematic review and metaanalysis. Am J Obstet Gynecol 209:40CrossRefPubMedCentral Conde-Agudelo A, Nieto A, Rosas-Bermudez A, Romero R (2013) Misoprostol to reduce intraoperative and postoperative hemorrhage during cesarean delivery: a systematic review and metaanalysis. Am J Obstet Gynecol 209:40CrossRefPubMedCentral
10.
go back to reference Soltan MH, El-Gendi E, Imam HH, Fathi O (2007) Different doses of sublingual misoprostol versus methylergometrine for the prevention of atonic postpartum haemorrhage. Int J Health Sci (Qassim). 1:229–236PubMedPubMedCentral Soltan MH, El-Gendi E, Imam HH, Fathi O (2007) Different doses of sublingual misoprostol versus methylergometrine for the prevention of atonic postpartum haemorrhage. Int J Health Sci (Qassim). 1:229–236PubMedPubMedCentral
11.
go back to reference Hofmeyr GJ, Gulmezoglu AM, Novikova N, Linder V, Ferreira S, Piaggio G (2009) Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects. Bull World Health Organ 87:666–677CrossRefPubMedPubMedCentral Hofmeyr GJ, Gulmezoglu AM, Novikova N, Linder V, Ferreira S, Piaggio G (2009) Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects. Bull World Health Organ 87:666–677CrossRefPubMedPubMedCentral
12.
go back to reference Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC (2002) Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod 17:332–336CrossRefPubMed Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC (2002) Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod 17:332–336CrossRefPubMed
13.
go back to reference El Tahan MR, Warda OM, Rashad A, Yasseen AM, Ramzy EA, Ahmady MS, Diab DG, Matter MK (2012) Effects of preoperative sublingual misoprostol on uterine tone during isoflurane anesthesia for cesarean section. Rev Bras Anestesiol 62:625–635CrossRefPubMed El Tahan MR, Warda OM, Rashad A, Yasseen AM, Ramzy EA, Ahmady MS, Diab DG, Matter MK (2012) Effects of preoperative sublingual misoprostol on uterine tone during isoflurane anesthesia for cesarean section. Rev Bras Anestesiol 62:625–635CrossRefPubMed
14.
go back to reference Ragab A, Barakat R, Alsammani MA (2016) A randomized clinical trial of preoperative versus postoperative misoprostol in elective cesarean delivery. Int J Gynaecol Obstet 132:82–84CrossRefPubMed Ragab A, Barakat R, Alsammani MA (2016) A randomized clinical trial of preoperative versus postoperative misoprostol in elective cesarean delivery. Int J Gynaecol Obstet 132:82–84CrossRefPubMed
15.
go back to reference Elsedeek MS (2012) Impact of preoperative rectal misoprostol on blood loss during and after elective cesarean delivery. Int J Gynaecol Obstet 118:149–152CrossRefPubMed Elsedeek MS (2012) Impact of preoperative rectal misoprostol on blood loss during and after elective cesarean delivery. Int J Gynaecol Obstet 118:149–152CrossRefPubMed
16.
go back to reference Rane A, Patole S, Singh M, Naidoo D, Buttener P (2003) Intravaginal Prostin gel prior to elective cesarean section at term to induce catecholamine surge in cord blood—a randomised, placebo controlled pilot study. Aust N Z J Obstet Gynecol 43:176 Rane A, Patole S, Singh M, Naidoo D, Buttener P (2003) Intravaginal Prostin gel prior to elective cesarean section at term to induce catecholamine surge in cord blood—a randomised, placebo controlled pilot study. Aust N Z J Obstet Gynecol 43:176
17.
go back to reference Singh M, Patole S, Rane A, Naidoo D, Buettner P (2004) Maternal intravaginal prostaglandin E2 gel before elective caesarean section at term to induce catecholamine surge in cord blood: randomised, placebo controlled study. Arch Dis Child Fetal Neonatal Ed 89:F131–135CrossRefPubMedPubMedCentral Singh M, Patole S, Rane A, Naidoo D, Buettner P (2004) Maternal intravaginal prostaglandin E2 gel before elective caesarean section at term to induce catecholamine surge in cord blood: randomised, placebo controlled study. Arch Dis Child Fetal Neonatal Ed 89:F131–135CrossRefPubMedPubMedCentral
18.
go back to reference National Collaborating Center for Women’s and Children’s Health (2011) Cesarean section: NICE clinical guideline. RCOG Press, London National Collaborating Center for Women’s and Children’s Health (2011) Cesarean section: NICE clinical guideline. RCOG Press, London
19.
go back to reference Phelan JP, Smith CV, Broussard P, Small M (1987) Amniotic fluid volume assessment with the four-quadrant technique at 36–42 weeks’ gestation. J Reprod Med 32:540–542PubMed Phelan JP, Smith CV, Broussard P, Small M (1987) Amniotic fluid volume assessment with the four-quadrant technique at 36–42 weeks’ gestation. J Reprod Med 32:540–542PubMed
20.
go back to reference Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM (2006) Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynecol Obstet 95:2–7CrossRef Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM (2006) Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynecol Obstet 95:2–7CrossRef
21.
go back to reference Chaudhuri P, Banerjee GB, Mandal A (2010) Rectally administered misoprostol versus intravenous oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss. Int J Gynecol Obstet 109:25–29CrossRef Chaudhuri P, Banerjee GB, Mandal A (2010) Rectally administered misoprostol versus intravenous oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss. Int J Gynecol Obstet 109:25–29CrossRef
22.
go back to reference Vimala N, Mittal S, Kumar S (2006) Sublingual misoprostol versus oxytocin infusion to reduce blood loss at cesarean section. Int J Gynecol Obstet 92:106–110CrossRef Vimala N, Mittal S, Kumar S (2006) Sublingual misoprostol versus oxytocin infusion to reduce blood loss at cesarean section. Int J Gynecol Obstet 92:106–110CrossRef
23.
go back to reference Tang OS, Ho PC (2006) The pharmacokinetics and different regimens of misoprostol in early first-trimester medical abortion. Contraception 74:26–30CrossRefPubMed Tang OS, Ho PC (2006) The pharmacokinetics and different regimens of misoprostol in early first-trimester medical abortion. Contraception 74:26–30CrossRefPubMed
24.
go back to reference Khan RU, El-Refaey H (2003) Pharmacokinetics and adverse-effect profile of rectally administered misoprostol in the third stage of labor. Obstet Gynecol 101:968–974PubMed Khan RU, El-Refaey H (2003) Pharmacokinetics and adverse-effect profile of rectally administered misoprostol in the third stage of labor. Obstet Gynecol 101:968–974PubMed
25.
go back to reference Owonikoko KM, Arowojolu AO, Okunlola MA (2011) Effect of sublingual misoprostol versus intravenous oxytocin on reducing blood loss at cesarean section in Nigeria: a randomized controlled trial. J Obstet Gynaecol Res 37:715–721CrossRefPubMed Owonikoko KM, Arowojolu AO, Okunlola MA (2011) Effect of sublingual misoprostol versus intravenous oxytocin on reducing blood loss at cesarean section in Nigeria: a randomized controlled trial. J Obstet Gynaecol Res 37:715–721CrossRefPubMed
26.
go back to reference Zhao Y, Li X, Peng Y (1998) [Clinical study on reduction of postpartum bleeding in cesarean section by misoprostol] (Article in Chinese). Zhonghua Fu Chan Ke Za Zhi 33:403–405PubMed Zhao Y, Li X, Peng Y (1998) [Clinical study on reduction of postpartum bleeding in cesarean section by misoprostol] (Article in Chinese). Zhonghua Fu Chan Ke Za Zhi 33:403–405PubMed
27.
go back to reference Fawole AO, Sotiloye OS, Hunyinbo KI, Umezulike AC, Okunlola MA, Adekanle DA, Osamor J, Adeyanju O, Olowookere OO, Adekunle AO, Singata M, Mangesi L, Hofmeyr GJ (2011) A double-blind, randomized, placebo-controlled trial of misoprostol and routine uterotonics for the prevention of postpartum hemorrhage. Int J Gynaecol Obstet 112:107–111CrossRefPubMed Fawole AO, Sotiloye OS, Hunyinbo KI, Umezulike AC, Okunlola MA, Adekanle DA, Osamor J, Adeyanju O, Olowookere OO, Adekunle AO, Singata M, Mangesi L, Hofmeyr GJ (2011) A double-blind, randomized, placebo-controlled trial of misoprostol and routine uterotonics for the prevention of postpartum hemorrhage. Int J Gynaecol Obstet 112:107–111CrossRefPubMed
28.
go back to reference Bhullar A, Carlan SJ, Hamm J, Lamberty N, White L, Richichi K (2004) Buccal misoprostol to decrease blood loss after vaginal delivery: a randomized trial. Obstet Gynecol 104:1282–1288CrossRefPubMed Bhullar A, Carlan SJ, Hamm J, Lamberty N, White L, Richichi K (2004) Buccal misoprostol to decrease blood loss after vaginal delivery: a randomized trial. Obstet Gynecol 104:1282–1288CrossRefPubMed
29.
go back to reference Fekih M, Jnifene A, Fathallah K, Ben Regaya L, Memmi A, Bouguizene S, Chaieb A, Bibi M, Khairi H (2009) Intérêt du misoprostol dans la prévention de l’hémorragie du post-partum immédiat en cas de césarienne: essai prospectif randomisé [Benefit of misoprostol for prevention of postpartum hemorrhage in cesarean section: a randomized controlled trial] (Article in French). J Gynecol Obstet Biol Reprod (Paris) 38:588–593CrossRefPubMed Fekih M, Jnifene A, Fathallah K, Ben Regaya L, Memmi A, Bouguizene S, Chaieb A, Bibi M, Khairi H (2009) Intérêt du misoprostol dans la prévention de l’hémorragie du post-partum immédiat en cas de césarienne: essai prospectif randomisé [Benefit of misoprostol for prevention of postpartum hemorrhage in cesarean section: a randomized controlled trial] (Article in French). J Gynecol Obstet Biol Reprod (Paris) 38:588–593CrossRefPubMed
30.
go back to reference Elati A, Weeks A (2012) Risk of fever after misoprostol for the prevention of postpartum hemorrhage: a meta-analysis. Obstet Gynecol 120:1140–1148CrossRefPubMed Elati A, Weeks A (2012) Risk of fever after misoprostol for the prevention of postpartum hemorrhage: a meta-analysis. Obstet Gynecol 120:1140–1148CrossRefPubMed
Metadata
Title
RETRACTED ARTICLE: Rectal vs. sublingual misoprostol before cesarean section: double-blind, three-arm, randomized clinical trial
Authors
Mohamed S. Sweed
Mourad M. El-Saied
Amgad E. Abou-Gamrah
Haitham A. El-Sabaa
Mohamed M. Abdel-Hamid
Hossam Hemeda
Ahmed M. Mansour
Mohamed E. Shawky
Medhat A. El-Sayed
Radwa M. Mohamed
Publication date
01-12-2018
Publisher
Springer Berlin Heidelberg
Published in
Archives of Gynecology and Obstetrics / Issue 6/2018
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI
https://doi.org/10.1007/s00404-018-4894-2

Other articles of this Issue 6/2018

Archives of Gynecology and Obstetrics 6/2018 Go to the issue