Delivery, ObstetricNCT03178461
The Effect of Warmed Parenteral Fluids During Delivery
A study testing Body temperature parenteral fluids in people with Delivery, Obstetric, run by Meir Medical Center at 2 sites in Israel.
Trial summary
To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery, Obstetric
- What is being tested?
- Body temperature parenteral fluids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jul 2017to 30 Dec 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancies
- term pregnancies
- receiving parenteral fluids
Who cannot join
- high order pregnancies
- preterm pregnancies (before 37 weeks of gestation)
- known fetal major anomaly
- known fetal significant chromosomal/genetic abnormality
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Hanoch Schreiber, MD, 972-53-332-3248, hanoch.schreiber@clalit.org.il
Yair Daykan, MD, 0542198231, yair.daykan@clalit.org.il
- Recruiting
Meir Medical Center
Kfar Saba
Hanoch Schreiber, 0533323248, Hanochsc@gmail.com
About this study
Official title: The Effect of Warmed Parenteral Fluids During Vaginal Delivery and Cesarean Section
To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.
Read the detailed description
Prospective randomized controlled trial. Assessing the influence of warmed parenteral fluids during delivery/cesarean section on the obstetrical and neonatal outcome. The investigators will randomize parturients during the active phase of labor to receive either body temperature warmed parenteral fluids or room temperature parenteral fluids. Both groups will receive the same fluid composition of 5% dextrose with normal saline. The investigators will compare the obstetrical and neonatal outcomes of the two groups.
- Conditions
- Delivery, Obstetric
- Being tested
- Body temperature parenteral fluids
- Keywords
- Caesarean Section, Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body temperature parenteral fluidsOther
2 study groups shall receive the same parenteral fluids but at different temperatures.
| Study group | Role | What they receive |
|---|---|---|
| Room temperature parenteral fluids | No intervention | This group will receive IV room temperature fluids, which is the standard of care. The composition of the fluids given will be normal saline with 5% dextrose. |
| Body temperature parenteral fluids | Experimental | This group will receive IV warmed fluids, body temperature, which is the experimental intervention.
The composition of the fluids given will be normal saline with 5% dextrose. Receives: Other: Body temperature parenteral fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of the second stage of labor
How much time did it take from complete cervical dilation to the delivery of the baby.
Measured: up to 5 hours from complete cervical dilation
Secondary outcomes (3)
Prevalence of perineal tears and episiotomies
The prevalence of perineal tears and episiotomies that occurred during vaginal delivery
Measured: immediately after vaginal birth
Neonatal APGAR score
Comparison of the 1 minute and 5 minute APGAR score that the neonates received, between the groups.
Measured: up to 5 minutes from delivery
The rate of prolonged second stage
The percentage of patients, in each group, that were defined with a prolonged second stage. The definition is more than 2 hours from complete cervical dilation until delivery of the baby in multipara patients and more than 3 hours from complete cervical dilation until delivery of the baby in nullipara patients.
Measured: immediately after completion of the delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery, ObstetricStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization two 2 groups according to temperature of IV fluids. One group will receive room temperature fluids and the other group will receive body temperature fluids.
- Masking
- None (open label)
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanoch schreiber, Meir Medical Center
- Investigators
- Hanoch Schreiber, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178461
- Sponsor's protocol ID
- 0049-17-MMC
- Status last verified
- Mar 2019
- First submitted
- 30 May 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All primary and secondary outcome measures will be made available within 6 months of syudy completion
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Warmed Parenteral Fluids During Vaginal Delivery and Cesarean Section
- ClinicalTrials.gov ID
- NCT03178461
- Acronym / sponsor ID
- 0049-17-MMC
- Conditions
- Delivery, Obstetric
- Keywords
- Caesarean Section, Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 7 Jun 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.
To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.
Detailed description
Prospective randomized controlled trial. Assessing the influence of warmed parenteral fluids during delivery/cesarean section on the obstetrical and neonatal outcome. The investigators will randomize parturients during the active phase of labor to receive either body temperature warmed parenteral fluids or room temperature parenteral fluids. Both groups will receive the same fluid composition of 5% dextrose with normal saline. The investigators will compare the obstetrical and neonatal outcomes of the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization two 2 groups according to temperature of IV fluids. One group will receive room temperature fluids and the other group will receive body temperature fluids.
| Arm | Type | Receives |
|---|---|---|
| Room temperature parenteral fluids | No intervention | –This group will receive IV room temperature fluids, which is the standard of care. The composition of the fluids given will be normal saline with 5% dextrose. |
| Body temperature parenteral fluids | Experimental | Other: Body temperature parenteral fluidsThis group will receive IV warmed fluids, body temperature, which is the experimental intervention. The composition of the fluids given will be normal saline with 5% dextrose. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancies
- term pregnancies
- receiving parenteral fluids
Key exclusion criteria (4 listed)
- high order pregnancies
- preterm pregnancies (before 37 weeks of gestation)
- known fetal major anomaly
- known fetal significant chromosomal/genetic abnormality
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 |
|---|---|---|
| Body temperature parenteral fluids2 study groups shall receive the same parenteral fluids but at different temperatures. | Other | Body temperature parenteral fluids |
Primary outcome
Length of the second stage of labor
Time frame: up to 5 hours from complete cervical dilation
How much time did it take from complete cervical dilation to the delivery of the baby.
3 secondary outcomes
Prevalence of perineal tears and episiotomies
Time frame: immediately after vaginal birth
Neonatal APGAR score
Time frame: up to 5 minutes from delivery
The rate of prolonged second stage
Time frame: immediately after completion of the delivery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: Yes. All primary and secondary outcome measures will be made available within 6 months of syudy completion
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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.
Hanoch Schreiber, MD principal investigator
Clalit Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body temperature parenteral fluids in people with Delivery, Obstetric, run by Meir Medical Center at 2 sites in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanoch Schreiber, MD (972-53-332-3248, hanoch.schreiber@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of the second stage of labor (time frame: up to 5 hours from complete cervical dilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2019.