Prolonged Second Stage of LaborPhase 4NITRONCT02265965
Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension
A Phase 4 study testing intravenous nitroglycerin in people with Prolonged Second Stage of Labor, run by University of California, San Francisco at 1 site in United States.
Trial summary
Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second stage arrest of descent to prevent or uterine extension at the hysterectomy site. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Second Stage of Labor
- What is being tested?
- intravenous nitroglycerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 1 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: women 37weeks or greater gestation diagnosed with second stage arrest of descent undergoing cesarean delivery -
Exclusion Criteria: elective, active phase arrest cesarean delivery, successful operative vaginal delivery
-
Trial locations and contacts
1 site in 1 country.
United States1 site
University California San Francisco-Labor and Delivery
San Francisco, California, 94143
About this study
Official title: Randomized Controlled Trial of IV Nitroglycerin in Cesarean Deliveries After Second Stage Arrest for the Prevention of Uterine Extension
Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second stage arrest of descent to prevent or uterine extension at the hysterectomy site.
Read the detailed description
Intravenous nitroglycerin resulting in uterine relaxation has been standardly utilized for various obstetrics conditions, e.g. breech extraction of second twin in vaginal deliveries, uterine relaxation after tachysystole in labor, prior to external cephalic version, and during difficult fetal extraction during cesarean delivery for arrest of descent in labor. Currently the use of nitroglycerin is at equipoise in obstetrics for difficult cesarean delivery after second stage arrest in labor. The clinical trial will randomize women who undergo cesarean delivery for second stage arrest in labor to receive IV nitroglycerin vs saline at the time of hysterotomy. The primary outcomes will be maternal: uterine extension, blood loss, total fetal extraction time, surgical time; neonatal: cord gases at delivery, apgar scores, admission to neonatal intensive care unit.
- Conditions
- Prolonged Second Stage of Labor
- Being tested
- intravenous nitroglycerin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous nitroglycerinDrug
Infusion at started at time of hysterotomy and stopped at neonate delivery
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Nitroglycerin | Experimental | Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered Receives: Drug: intravenous nitroglycerin |
| Intravenous Saline | No intervention | Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Uterine Extension of Hysterotomy
Obstetrician determined whether the subject had an uterine extension.
Measured: During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Umbilical Artery Blood pH
Measure of umbilical artery blood pH
Measured: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Number of Participants With Deliveries After Which Neonate is Admitted to NICU
Measured: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12
A cord blood base deficit more negative than negative 12 is abnormal and a sign of metabolic acidosis.
Measured: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
APGAR at 5 Minutes
The APGAR scale is determined by evaluating the newborn baby on five simple criteria -- Appearance, Pulse, Grimace, Activity, Respiration -- on a scale from zero to two, then summing up the five values thus obtained. The resulting APGAR score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.
Measured: Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Secondary outcomes (3)
Fetal Extraction Time in Seconds
Time from uterine incision to delivery (body of neonate fully extracted from uterus)
Measured: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Total Operative Time in Minutes
Time from uterine incision to out of room
Measured: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Surgical Blood Loss
Total blood loss will be measured
Measured: During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2015
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Second Stage of LaborStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer M Lucero, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265965
- Sponsor's protocol ID
- UCSF-OB-NTG
- Acronym
- NITRO
- Status last verified
- May 2020
- First submitted
- 22 Sep 2014
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Isquick S, Henry D, Nakagawa S, Moghadassi M, Thiet MP, Norton M, Lucero J. The association between nitroglycerin use and adverse outcomes in women undergoing cesarean delivery in the second stage of labor. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1297-1301. doi: 10.1080/14767058.2016.1212010. Epub 2016 Aug 2.
PubMed 27405400
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of IV Nitroglycerin in Cesarean Deliveries After Second Stage Arrest for the Prevention of Uterine Extension
- ClinicalTrials.gov ID
- NCT02265965
- Acronym / sponsor ID
- NITRO / UCSF-OB-NTG
- Conditions
- Prolonged Second Stage of Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Posted 19 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second stage arrest of descent to prevent or uterine extension at the hysterectomy site.
Detailed description
Intravenous nitroglycerin resulting in uterine relaxation has been standardly utilized for various obstetrics conditions, e.g. breech extraction of second twin in vaginal deliveries, uterine relaxation after tachysystole in labor, prior to external cephalic version, and during difficult fetal extraction during cesarean delivery for arrest of descent in labor. Currently the use of nitroglycerin is at equipoise in obstetrics for difficult cesarean delivery after second stage arrest in labor. The clinical trial will randomize women who undergo cesarean delivery for second stage arrest in labor to receive IV nitroglycerin vs saline at the time of hysterotomy. The primary outcomes will be maternal: uterine extension, blood loss, total fetal extraction time, surgical time; neonatal: cord gases at delivery, apgar scores, admission to neonatal intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Nitroglycerin | Experimental | Drug: intravenous nitroglycerinSubjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered |
| Intravenous Saline | No intervention | –Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| intravenous nitroglycerinInfusion at started at time of hysterotomy and stopped at neonate delivery | Drug | Intravenous Nitroglycerin |
Primary outcome
Number of Participants With Uterine Extension of Hysterotomy
Time frame: During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Obstetrician determined whether the subject had an uterine extension.
Umbilical Artery Blood pH
Time frame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Measure of umbilical artery blood pH
Number of Participants With Deliveries After Which Neonate is Admitted to NICU
Time frame: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12
Time frame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
A cord blood base deficit more negative than negative 12 is abnormal and a sign of metabolic acidosis.
APGAR at 5 Minutes
Time frame: Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
The APGAR scale is determined by evaluating the newborn baby on five simple criteria -- Appearance, Pulse, Grimace, Activity, Respiration -- on a scale from zero to two, then summing up the five values thus obtained. The resulting APGAR score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.
3 secondary outcomes
Fetal Extraction Time in Seconds
Time frame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Total Operative Time in Minutes
Time frame: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Surgical Blood Loss
Time frame: During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27405400Isquick S, Henry D, Nakagawa S, Moghadassi M, Thiet MP, Norton M, Lucero J. The association between nitroglycerin use and adverse outcomes in women undergoing cesarean delivery in the second stage of labor. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1297-1301. doi: 10.1080/14767058.2016.1212010. Epub 2016 Aug 2.
- Individual participant dataSharing planned: No
Related trials for Prolonged Second Stage of Labor
Recruiting
Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery
Prolonged Second Stage of Labor
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.
Jennifer M Lucero, MD principal investigator
University of California, San Francisco
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 intravenous nitroglycerin in people with Prolonged Second Stage of Labor, run by University of California, San Francisco 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?
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 19 May 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. 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?
Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Uterine Extension of Hysterotomy (time frame: During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest). The study lists 5 primary outcomes in all. 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 NCT02265965, which also lists 1 linked publication.
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 19 May 2020.