- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03246919
Ideal Time of Oxytocin Infusion During Cesarean Section (I-TOPICS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.
This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Women undergoing cesarean section at Loyola Hospital
- Women who read and speak the English and/or Spanish language
- Women age 18 or older
Exclusion Criteria:
- Women who deliver vaginally
- Gestation under 37 weeks and 0 days
- Women with coagulopathies
- Multiple gestation pregnancies
- Antepartum hemorrhage for example abruption
- Placental abnormalities for example previa, accreta
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Control (Group A)
One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers.
After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia.
This amount of fluid is part of standard of care.
|
Placebo will be administered after delivery of the placenta
|
Aktiv komparator: Intervention (Group B)
One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers.
After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia.
This amount of fluid is part of standard of care.
|
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Total blood loss
Tidsramme: At the completion of the surgery when patient is transferred to recovery from the operating room
|
Both the estimated blood loss and quantitative blood loss will be determined
|
At the completion of the surgery when patient is transferred to recovery from the operating room
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of postpartum hemorrhage
Tidsramme: At the completion of the surgery when patient is transferred to recovery from the operating room
|
The number of women who lose 1,000 milliliters or more blood from cesarean delivery
|
At the completion of the surgery when patient is transferred to recovery from the operating room
|
Need for transfusion
Tidsramme: In the immediate 24 hours post surgery
|
The number of women who require a blood transfusion due to surgical blood loss
|
In the immediate 24 hours post surgery
|
Change in pre-operative to post-operative hemoglobin levels
Tidsramme: Baseline and Post operative day number 1
|
Hemoglobin levels
|
Baseline and Post operative day number 1
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Thaddeus Waters, MD, Loyola University
Publikationer og nyttige links
Generelle publikationer
- 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.
- Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.
- Jackson KW Jr, Allbert JR, Schemmer GK, Elliot M, Humphrey A, Taylor J. A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum hemorrhage. Am J Obstet Gynecol. 2001 Oct;185(4):873-7. doi: 10.1067/mob.2001.117363.
- WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
- Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.
- Fidan U, Keskin U, Ulubay M, Efendi Karaca R, Burcin Firatligil F, Goksen Kocagoz G, Ergun A. The effect of the use of oxytocin on blood loss during different postpartum periods. J Perinat Med. 2015 Jul;43(4):461-5. doi: 10.1515/jpm-2014-0111.
- Khan FA, Khan M, Ali A, Chohan U. Estimation of blood loss during Caesarean section: an audit. J Pak Med Assoc. 2006 Dec;56(12):572-5.
- Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
- National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists
- Silverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 209632
Plan for individuelle deltagerdata (IPD)
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