Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery

NCT02411916 | Completed Results

• 1 other identifier: QHC11-237
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin

  1 day after delivery

Study Arms (2)

intervention cases

EXPERIMENTAL

patient receiving misoprostol

Biological: misoprostol

controls

NO INTERVENTION

patients not receiving misoprostol

Interventions

misoprostol BIOLOGICAL

rectal insertion

Also known as: cytotec

intervention cases

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Recruiting only pregnant women prior to child-birth delivery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit
• She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit
• She has had fewer than four prior vaginal deliveries.
• She reports no allergy to misoprostol.
• The following factors or conditions will exclude a patient from consideration as a subject:
• The fetus has a known major fetal malformation or chromosome abnormality
• The gestation is multiple.
• There is a breech or other malpresentation
• The patient reports involvement in another clinical trial currently or previously in this pregnancy.
• The patient is expected to have a cesarean delivery.
• The patient had a prior cesarean delivery.
• There has been an intrauterine fetal death.
• There is polyhydramnios (amniotic fluid index \>22 cm).
• Presence of acute or chronic renal disease
• Presence of preeclampsia

You may not qualify if:

• Unanticipated cesarean delivery.
• Performance of episiotomy (third and fourth degree extensions will be excluded).
• Vaginal or cervical laceration, or perineal laceration of more than second degree in depth.
• Severe postpartum hemorrhage requiring intervention immediately after delivery.
• Uterine rupture
• Placental abruption.
• Patient withdrawal of consent.

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

Related Publications (22)

• 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.

  PMID: 19461428 BACKGROUND

• Cohen WR. Hemorrhagic shock in obstetrics. J Perinat Med. 2006;34(4):263-71. doi: 10.1515/JPM.2006.051.

  PMID: 16856813 BACKGROUND

• Pontieri-Lewis V. The role of nutrition in wound healing. Medsurg Nurs. 1997 Aug;6(4):187-90, 221; quiz 191-2.

  PMID: 9313545 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.

  PMID: 19898894 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.

  PMID: 19772612 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.

  PMID: 20151087 BACKGROUND

• Chelmow D. Postpartum haemorrhage: prevention. BMJ Clin Evid. 2011 Apr 4;2011:1410.

  PMID: 21463537 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.

  PMID: 21199290 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.

  PMID: 20687079 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.

  PMID: 11687123 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.

  PMID: 16781257 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.

  PMID: 21466519 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.

  PMID: 18001447 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.

  PMID: 19249048 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.

  PMID: 20422423 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.

  PMID: 18441726 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.

  PMID: 11531635 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.

  PMID: 19377430 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.

  PMID: 15592308 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.

  PMID: 19395364 BACKGROUND

• Garris RE, Kirkwood CF. Misoprostol: a prostaglandin E1 analogue. Clin Pharm. 1989 Sep;8(9):627-44.

  PMID: 2507215 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Dr. Aleksandr Fuks
• Organization: Queens Hospital Center

fuksal@nychhc.org

718 883-4035

Study Officials

• Aleksandr Fuks, MD

  Queens Hopsital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Directore, Department OB / GYN , Queens Hospital Center

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: March 30, 2012
• Primary Completion: February 16, 2019
• Study Completion: February 16, 2019
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Locations

US (1)