Blood Loss, SurgicalPhase 4I-TOPICSNCT03246919
Ideal Time of Oxytocin Infusion During Cesarean Section
A Phase 4 study testing Oxytocin in people with Blood Loss, Surgical and Postpartum Hemorrhage, run by Loyola University at 1 site in United States.
Trial summary
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical, Postpartum Hemorrhage, Bleed Pregnancy
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 24 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing cesarean section at Loyola Hospital
- Women who read and speak the English and/or Spanish language
- Women age 18 or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.
Read the detailed description
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.
- Conditions
- Blood Loss, Surgical, Postpartum Hemorrhage, Bleed Pregnancy, Pregnancy Related, Cesarean Section Complications
- Being tested
- Oxytocin, Placebo
- Medical subject headings
- Blood Loss, Surgical, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
PlaceboDrug
Placebo will be administered after delivery of the placenta
| Study group | Role | What they receive |
|---|---|---|
| Control (Group A) | Placebo comparator | 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. Receives: Drug: Placebo |
| Intervention (Group B) | Active comparator | 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. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss
Both the estimated blood loss and quantitative blood loss will be determined
Measured: At the completion of the surgery when patient is transferred to recovery from the operating room
Secondary outcomes (3)
Incidence of postpartum hemorrhage
The number of women who lose 1,000 milliliters or more blood from cesarean delivery
Measured: At the completion of the surgery when patient is transferred to recovery from the operating room
Need for transfusion
The number of women who require a blood transfusion due to surgical blood loss
Measured: In the immediate 24 hours post surgery
Change in pre-operative to post-operative hemoglobin levels
Hemoglobin levels
Measured: Baseline and Post operative day number 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start13 Sep 2017
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Why it stopped: PI left Loyola and Sub-I graduated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thaddeus Waters, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246919
- Sponsor's protocol ID
- 209632
- Acronym
- I-TOPICS
- Status last verified
- Aug 2019
- First submitted
- 4 Aug 2017
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11641669Soltani 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.
PubMed 20687079Fidan 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.
PubMed 24897394Oguz 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.
PubMed 25108586Dahlke 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.
PubMed 23467047Khan 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.
PubMed 17312645Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
PubMed 17390600WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
PubMed 23586122National 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Time of Oxytocin Infusion During Cesarean Section
- ClinicalTrials.gov ID
- NCT03246919
- Acronym / sponsor ID
- I-TOPICS / 209632
- Conditions
- Blood Loss, Surgical, Postpartum Hemorrhage, Bleed Pregnancy, Pregnancy Related, Cesarean Section Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left Loyola and Sub-I graduated.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Group A) | Placebo comparator | Drug: PlaceboOne 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. |
| Intervention (Group B) | Active comparator | Drug: OxytocinOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women undergoing cesarean section at Loyola Hospital
- Women who read and speak the English and/or Spanish language
- Women age 18 or older
Key exclusion criteria (6 listed)
- Women who deliver vaginally
- Gestation under 37 weeks and 0 days
- Women with coagulopathies
- Multiple gestation pregnancies
- Antepartum hemorrhage for example abruption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: PitocinOxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta | Drug | Intervention (Group B) |
| PlaceboPlacebo will be administered after delivery of the placenta | Drug | Control (Group A) |
Primary outcome
Total blood loss
Time frame: 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
3 secondary outcomes
Incidence of postpartum hemorrhage
Time frame: At the completion of the surgery when patient is transferred to recovery from the operating room
Need for transfusion
Time frame: In the immediate 24 hours post surgery
Change in pre-operative to post-operative hemoglobin levels
Time frame: Baseline and Post operative day number 1
Results and safety
The study was stopped early (reason given: PI left Loyola and Sub-I graduated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Background: PubMed 11641669Jackson 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.
- Background: PubMed 20687079Soltani 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: PubMed 24897394Fidan 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.
- Background: PubMed 25108586Oguz 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.
- Background: PubMed 23467047Dahlke 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.
- Background: PubMed 17312645Khan 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.
- Background: PubMed 17390600Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
- Background: PubMed 23586122WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
- BackgroundNational Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists
- BackgroundSilverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thaddeus Waters, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin in people with Blood Loss, Surgical and Postpartum Hemorrhage, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left Loyola and Sub-I graduated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood loss (time frame: At the completion of the surgery when patient is transferred to recovery from the operating room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246919, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.