Postpartum HemorrhagePROCEEDINGNCT04632264
Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping
A study testing Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery and Initiation of standard postpartum oxytocin immediately following placenta delivery in people with Postpartum Hemorrhage, run by Columbia University at 1 site in United States.
Trial summary
Increased blood loss after vaginal or cesarean delivery is one of the top causes of maternal complications. Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery. The investigators do not know the best time after delivery that oxytocin should be given. 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
- Postpartum Hemorrhage
- What is being tested?
- Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery and Initiation of standard postpartum oxytocin immediately following placenta delivery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 16 Sep 2021
- Phase
- Interventional
- 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
- All laboring women (induced, augmented, or spontaneous) at term admitted to Labor and Delivery while comfortable
- Scheduled cesareans
- Women aged 18 years or older
- Admitted at NewYork-Presbyterian Morgan Stanley Children's Hospital (CHONY) or Allen Pavilion Labor and Delivery units
Who cannot join
- Multifetal gestation
- Placental abruption or antepartum hemorrhage
- Maternal bleeding disorder
- Known fetal anomaly or anemia
- Fetal growth restriction with abnormal Doppler
- Significant maternal anemia (pre-operative hemoglobin ≤ 7g/dL
Show all 13Show fewer
- Intrapartum stillbirth
- Placenta accreta spectrum
- Abnormal placentation (previa or abruption)
- Planned cord blood banking
- Refusal of blood products
- Any contraindication for delayed cord clamping
- Maternal history of aortic stenosis or pulmonary hypertension or other severe cardiac structural disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Optimal Timing of Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping - PROCEEDING (PostpaRtum OxytoCin Era dElayed corD clampING) Study
Increased blood loss after vaginal or cesarean delivery is one of the top causes of maternal complications. Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery. The investigators do not know the best time after delivery that oxytocin should be given. This research is being done to find out if starting the medication oxytocin right after the baby is born or after the placenta comes out decreases the amount of blood lost after birth when we delay cord clamping after birth.
Read the detailed description
The optimal timing of prophylactic oxytocin administration on both maternal and neonatal outcomes has not been definitively established with delayed cord clamping. Maternal considerations include the risk of postpartum hemorrhage, need for additional uterotonic medications, need for maternal transfusion, retained placenta, and postpartum drop in hemoglobin. Neonatal considerations include markers of neonatal well-being such as arterial pH and 5-minute Apgar score, as well as hemoglobin and bilirubin levels. There is currently no protocol on the timing of third stage prophylactic oxytocin and its administration is based on physician/ delivery provider's preference. The investigators propose a quality assessment initiative, through a randomized controlled trial designed to compare the blood loss between administrations of prophylactic oxytocin immediately after delivery of the neonate versus after delivery of the placenta with delayed cord clamping.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery, Initiation of standard postpartum oxytocin immediately following placenta delivery, Saline Placebo
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of standard postpartum oxytocin immediately following fetal shoulder deliveryOther
The intervention is to determine if initiating oxytocin as soon as the fetus is delivered decreased postpartum blood loss. 30 units in 500 milliliters of 0.9% sodium chloride
Initiation of standard postpartum oxytocin immediately following placenta deliveryOther
Standard of care includes oxytocin administration post-delivery regardless of delivery mode. This is the comparative group. 30 units in 500 milliliters of 0.9% sodium chloride
Saline PlaceboOther
Saline placebo will be initiated post placenta delivery (within 15 seconds).
Saline PlaceboOther
Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds).
| Study group | Role | What they receive |
|---|---|---|
| Pre-placental group | Experimental | Oxytocin will be initiated immediately after delivery of the neonatal anterior shoulder (within 15 seconds). This is our "intervention" group. Saline placebo will be initiated post placenta delivery (within 15 seconds). Receives: Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery; Other: Saline Placebo |
| Post-placental group | Other | Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds). Receives: Other: Initiation of standard postpartum oxytocin immediately following placenta delivery; Other: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin
Change defined as greater or equal to 1.0 g/dL (≥ 1 standard deviation (SD)) hemoglobin drop between the two arms following a vaginal delivery and greater or equal to 0.9 g/dL (≥ 1SD) following a cesarean delivery.
Measured: Up to 24 hours
Secondary outcomes (2)
Cumulative Maternal Adverse Outcomes
Any adverse maternal outcome (adverse event) including blood transfusion or symptomatic anemia.
Measured: Postpartum, Up to 6 weeks
Cumulative Neonatal Adverse Outcomes
Any adverse neonatal outcome (adverse event) including jaundice, hematocrit laboratory abnormality.
Measured: Post Delivery, Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start10 Dec 2020
- Primary completion2 Apr 2021
- Study completion16 Sep 2021
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 Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel randomized, placebo-controlled, and double-blinded studies. For this study we will include 52 scheduled cesarean sections and 52 vaginal deliveries as two separate cohorts.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie E. Purish, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632264
- Sponsor's protocol ID
- AAAS9154
- Acronym
- PROCEEDING
- Status last verified
- Dec 2021
- First submitted
- 14 Nov 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
PubMed 23843134Soltani 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 20687079GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1775-1812. doi: 10.1016/S0140-6736(16)31470-2.
PubMed 27733286Rana N, Kc A, Malqvist M, Subedi K, Andersson O. Effect of Delayed Cord Clamping of Term Babies on Neurodevelopment at 12 Months: A Randomized Controlled Trial. Neonatology. 2019;115(1):36-42. doi: 10.1159/000491994. Epub 2018 Oct 2.
PubMed 30278462Andersson O, Lindquist B, Lindgren M, Stjernqvist K, Domellof M, Hellstrom-Westas L. Effect of Delayed Cord Clamping on Neurodevelopment at 4 Years of Age: A Randomized Clinical Trial. JAMA Pediatr. 2015 Jul;169(7):631-8. doi: 10.1001/jamapediatrics.2015.0358.
PubMed 26010418Andersson O, Hellstrom-Westas L, Andersson D, Domellof M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157. doi: 10.1136/bmj.d7157.
PubMed 22089242Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
PubMed 28002310Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995.
PubMed 31742629Hamm RF, Wang EY, Bastek JA, Srinivas SK. Assessing reVITALize: Should the Definition of Postpartum Hemorrhage Differ by Mode of Delivery? Am J Perinatol. 2017 Apr;34(5):503-507. doi: 10.1055/s-0036-1593535. Epub 2016 Oct 12.
PubMed 27732984Jackson 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 11641669
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping - PROCEEDING (PostpaRtum OxytoCin Era dElayed corD clampING) Study
- ClinicalTrials.gov ID
- NCT04632264
- Acronym / sponsor ID
- PROCEEDING / AAAS9154
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 17 Nov 2020 (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.
Increased blood loss after vaginal or cesarean delivery is one of the top causes of maternal complications. Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery. The investigators do not know the best time after delivery that oxytocin should be given. This research is being done to find out if starting the medication oxytocin right after the baby is born or after the placenta comes out decreases the amount of blood lost after birth when we delay cord clamping after birth.
Detailed description
The optimal timing of prophylactic oxytocin administration on both maternal and neonatal outcomes has not been definitively established with delayed cord clamping. Maternal considerations include the risk of postpartum hemorrhage, need for additional uterotonic medications, need for maternal transfusion, retained placenta, and postpartum drop in hemoglobin. Neonatal considerations include markers of neonatal well-being such as arterial pH and 5-minute Apgar score, as well as hemoglobin and bilirubin levels. There is currently no protocol on the timing of third stage prophylactic oxytocin and its administration is based on physician/ delivery provider's preference. The investigators propose a quality assessment initiative, through a randomized controlled trial designed to compare the blood loss between administrations of prophylactic oxytocin immediately after delivery of the neonate versus after delivery of the placenta with delayed cord clamping.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Two parallel randomized, placebo-controlled, and double-blinded studies. For this study we will include 52 scheduled cesarean sections and 52 vaginal deliveries as two separate cohorts.
| Arm | Type | Receives |
|---|---|---|
| Pre-placental group | Experimental | Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery, Other: Saline PlaceboOxytocin will be initiated immediately after delivery of the neonatal anterior shoulder (within 15 seconds). This is our "intervention" group. Saline placebo will be initiated post placenta delivery (within 15 seconds). |
| Post-placental group | Other | Other: Initiation of standard postpartum oxytocin immediately following placenta delivery, Other: Saline PlaceboSaline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All laboring women (induced, augmented, or spontaneous) at term admitted to Labor and Delivery while comfortable
- Scheduled cesareans
- Women aged 18 years or older
- Admitted at NewYork-Presbyterian Morgan Stanley Children's Hospital (CHONY) or Allen Pavilion Labor and Delivery units
Key exclusion criteria (13 listed)
- Multifetal gestation
- Placental abruption or antepartum hemorrhage
- Maternal bleeding disorder
- Known fetal anomaly or anemia
- Fetal growth restriction with abnormal Doppler
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 |
|---|---|---|
| Initiation of standard postpartum oxytocin immediately following fetal shoulder deliveryThe intervention is to determine if initiating oxytocin as soon as the fetus is delivered decreased postpartum blood loss. 30 units in 500 milliliters of 0.9% sodium chloride | Other | Pre-placental group |
| Initiation of standard postpartum oxytocin immediately following placenta deliveryStandard of care includes oxytocin administration post-delivery regardless of delivery mode. This is the comparative group. 30 units in 500 milliliters of 0.9% sodium chloride | Other | Post-placental group |
| Saline PlaceboSaline placebo will be initiated post placenta delivery (within 15 seconds). | Other | Pre-placental group |
| Saline PlaceboSaline placebo will be initiated post fetal shoulder delivery (within 15 seconds). | Other | Post-placental group |
Primary outcome
Change in Hemoglobin
Time frame: Up to 24 hours
Change defined as greater or equal to 1.0 g/dL (≥ 1 standard deviation (SD)) hemoglobin drop between the two arms following a vaginal delivery and greater or equal to 0.9 g/dL (≥ 1SD) following a cesarean delivery.
2 secondary outcomes
Cumulative Maternal Adverse Outcomes
Time frame: Postpartum, Up to 6 weeks
Cumulative Neonatal Adverse Outcomes
Time frame: Post Delivery, Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Background: PubMed 23843134McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
- 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 27733286GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1775-1812. doi: 10.1016/S0140-6736(16)31470-2.
- Background: PubMed 30278462Rana N, Kc A, Malqvist M, Subedi K, Andersson O. Effect of Delayed Cord Clamping of Term Babies on Neurodevelopment at 12 Months: A Randomized Controlled Trial. Neonatology. 2019;115(1):36-42. doi: 10.1159/000491994. Epub 2018 Oct 2.
- Background: PubMed 26010418Andersson O, Lindquist B, Lindgren M, Stjernqvist K, Domellof M, Hellstrom-Westas L. Effect of Delayed Cord Clamping on Neurodevelopment at 4 Years of Age: A Randomized Clinical Trial. JAMA Pediatr. 2015 Jul;169(7):631-8. doi: 10.1001/jamapediatrics.2015.0358.
- Background: PubMed 22089242Andersson O, Hellstrom-Westas L, Andersson D, Domellof M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157. doi: 10.1136/bmj.d7157.
- Background: PubMed 28002310Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
- Background: PubMed 31742629Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995.
- Background: PubMed 27732984Hamm RF, Wang EY, Bastek JA, Srinivas SK. Assessing reVITALize: Should the Definition of Postpartum Hemorrhage Differ by Mode of Delivery? Am J Perinatol. 2017 Apr;34(5):503-507. doi: 10.1055/s-0036-1593535. Epub 2016 Oct 12.
- 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.
- 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.
Stephanie E. Purish, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery and Initiation of standard postpartum oxytocin immediately following placenta delivery in people with Postpartum Hemorrhage, run by Columbia 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 29 Dec 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Hemoglobin (time frame: Up to 24 hours). 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 NCT04632264, 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 29 Dec 2021.