Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery

Summary

This document defines the Clinical Investigation Protocol for a study designed to determine whether blood loss after spontaneous vaginal delivery is altered by the addition of misoprostol administration to the standard use of intravenous oxytocin after delivery. The protocol is an open-label randomized prospective trial to be carried out at Queens Hospital Center. Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit levels on admission in labor to those obtained within 24 hours after delivery.

Timeline

Start

2012-03-30

Primary completion

2019-02-16

Completion

2019-02-16

Publications

• Background Pritchard JA, Baldwin RM, Dickey JC, et al. Blood volume changes in pregnancy and the puerperium, 2. Red blood cell loss and changes in apparent blood volume during and following vaginal delivery, cesarean section, and cesarean section plus total hysterectomy. Am J Obstet Gynecol 1962;84:1271-1282.
• Background Sosa CG, Althabe F, Belizan JM, Buekens P. Risk factors for postpartum hemorrhage in vaginal deliveries in a Latin-American population. Obstet Gynecol. 2009 Jun;113(6):1313-1319. doi: 10.1097/AOG.0b013e3181a66b05.
• Background Cohen WR. Hemorrhagic shock in obstetrics. J Perinat Med. 2006;34(4):263-71. doi: 10.1515/JPM.2006.051.
• Background Pontieri-Lewis V. The role of nutrition in wound healing. Medsurg Nurs. 1997 Aug;6(4):187-90, 221; quiz 191-2.
• Background van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y.
• Background Ezechi OC, Edet A, Akinlade H, Gab-Okafor CV, Herbertson E. Incidence and risk factors for caesarean wound infection in Lagos Nigeria. BMC Res Notes. 2009 Sep 22;2:186. doi: 10.1186/1756-0500-2-186.
• Background Teixeira Mde L, Lira PI, Coutinho SB, Eickmann SH, Lima MC. Influence of breastfeeding type and maternal anemia on hemoglobin concentration in 6-month-old infants. J Pediatr (Rio J). 2010 Jan-Feb;86(1):65-72. doi: 10.2223/JPED.1959.
• Background Chelmow D. Postpartum haemorrhage: prevention. BMJ Clin Evid. 2011 Apr 4;2011:1410.
• Background Elati A, Elmahaishi MS, Elmahaishi MO, Elsraiti OA, Weeks AD. The effect of misoprostol on postpartum contractions: a randomised comparison of three sublingual doses. BJOG. 2011 Mar;118(4):466-73. doi: 10.1111/j.1471-0528.2010.02821.x. Epub 2010 Dec 24.
• Background Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.
• Background Elbourne DR, Prendiville WJ, Carroli G, Wood J, McDonald S. Prophylactic use of oxytocin in the third stage of labour. Cochrane Database Syst Rev. 2001;(4):CD001808. doi: 10.1002/14651858.CD001808.
• Background Gemzell-Danielsson K, Bygdeman M, Aronsson A. Studies on uterine contractility following mifepristone and various routes of misoprostol. Contraception. 2006 Jul;74(1):31-5. doi: 10.1016/j.contraception.2006.03.009. Epub 2006 Apr 27.
• Background Cabrera Y, Fernandez-Guisasola J, Lobo P, Gamir S, Alvarez J. Comparison of sublingual versus vaginal misoprostol for second-trimester pregnancy termination: a meta-analysis. Aust N Z J Obstet Gynaecol. 2011 Apr;51(2):158-65. doi: 10.1111/j.1479-828X.2010.01264.x. Epub 2011 Jan 6.
• Background Enakpene CA, Morhason-Bello IO, Enakpene EO, Arowojolu AO, Omigbodun AO. Oral misoprostol for the prevention of primary post-partum hemorrhage during third stage of labor. J Obstet Gynaecol Res. 2007 Dec;33(6):810-7. doi: 10.1111/j.1447-0756.2007.00661.x.
• Background Nasr A, Shahin AY, Elsamman AM, Zakherah MS, Shaaban OM. Rectal misoprostol versus intravenous oxytocin for prevention of postpartum hemorrhage. Int J Gynaecol Obstet. 2009 Jun;105(3):244-7. doi: 10.1016/j.ijgo.2009.01.018. Epub 2009 Feb 26.
• Background Mansouri HA, Alsahly N. Rectal versus oral misoprostol for active management of third stage of labor: a randomized controlled trial. Arch Gynecol Obstet. 2011 May;283(5):935-9. doi: 10.1007/s00404-010-1466-5. Epub 2010 Apr 27.
• Background Baruah M, Cohn GM. Efficacy of rectal misoprostol as second-line therapy for the treatment of primary postpartum hemorrhage. J Reprod Med. 2008 Mar;53(3):203-6.
• Background Lokugamage AU, Sullivan KR, Niculescu I, Tigere P, Onyangunga F, El Refaey H, Moodley J, Rodeck CH. A randomized study comparing rectally administered misoprostol versus Syntometrine combined with an oxytocin infusion for the cessation of primary post partum hemorrhage. Acta Obstet Gynecol Scand. 2001 Sep;80(9):835-9. doi: 10.1034/j.1600-0412.2001.080009835.x.
• Background Haque N, Bilkis L, Haque N, Bari MS, Haque S. Comparative study between rectally administered misoprostol as a prophylaxis versus conventional intramuscular oxytocin in post partum hemorrhage. Mymensingh Med J. 2009 Jan;18(1 Suppl):S40-44.
• Background Vogel D, Burkhardt T, Rentsch K, Schweer H, Watzer B, Zimmermann R, Von Mandach U. Misoprostol versus methylergometrine: pharmacokinetics in human milk. Am J Obstet Gynecol. 2004 Dec;191(6):2168-73. doi: 10.1016/j.ajog.2004.05.008.
• Background Tang OS, Schweer H, Lee SW, Ho PC. Pharmacokinetics of repeated doses of misoprostol. Hum Reprod. 2009 Aug;24(8):1862-9. doi: 10.1093/humrep/dep108. Epub 2009 Apr 23.
• Background Garris RE, Kirkwood CF. Misoprostol: a prostaglandin E1 analogue. Clin Pharm. 1989 Sep;8(9):627-44.

Drugs

Indications

No indication recorded.