Labor Stage, FirstNCT01242293
Intrapartum Hydration
A study testing 0.9% Saline with glucose 5% and Ringer lactate in people with Labor Stage, First and Labor Stage, Second, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Stage, First, Labor Stage, Second
- What is being tested?
- 0.9% Saline with glucose 5% and Ringer lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to Aug 2015
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women
- Gestational age 37-41 weeks
- Cervical dilatation 1-3 cm
- Vertex presentation
- Singleton
Who cannot join
- Diabetes
- Preeclampsia
- Intra uterine fetal growth restriction
- Duration of labor less than an hour
- Maternal chronic disease
- Maternal fever upon admission.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.
Read the detailed description
During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.
- Conditions
- Labor Stage, First, Labor Stage, Second
- Being tested
- 0.9% Saline with glucose 5%, Ringer lactate, Ringer lactate - Controls
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Saline with glucose 5%Other
intravenous hydration at a rate of 125 ml per hour during labor
Ringer lactateOther
intravenous hydration at a rate of 250 ml per hour during labor
Ringer lactate - ControlsOther
intravenous hydration at a rate of 125 ml per hour during labor
| Study group | Role | What they receive |
|---|---|---|
| 0.9% Saline with glucose 5% | Active comparator | rate of infusion is 125cc/h Receives: Other: 0.9% Saline with glucose 5% |
| Ringer lactate | Active comparator | rate of infusion is 250cc/h Receives: Other: Ringer lactate |
| Ringer lactate - Controls | Active comparator | rate of infusion is 125cc/h Receives: Other: Ringer lactate - Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time from enrollment until delivery
Measured: within the first 48 hours after delivery
Secondary outcomes (2)
Mode of delivery
Measured: within the first 48 hours after delivery
Neonatal outcome
Measured: within the first 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor Stage, FirstStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raed Salim, HaEmek Medical Center, Israel
- Investigators
- Raed Salim, MD, Principal investigator, Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242293
- Sponsor's protocol ID
- 0062-10-EMC
- Other IDs
- IH-1
- Status last verified
- Feb 2016
- First submitted
- 15 Nov 2010
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garmi G, Zuarez-Easton S, Zafran N, Ohel I, Berkovich I, Salim R. The effect of type and volume of fluid hydration on labor duration of nulliparous women: a randomized controlled trial. Arch Gynecol Obstet. 2017 Jun;295(6):1407-1412. doi: 10.1007/s00404-017-4381-1. Epub 2017 May 3.
PubMed 28470550
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Hydration
- ClinicalTrials.gov ID
- NCT01242293
- Acronym / sponsor ID
- 0062-10-EMC
- Conditions
- Labor Stage, First, Labor Stage, Second
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Nov 2010 (estimated)
- 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.
The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.
Detailed description
During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.9% Saline with glucose 5% | Active comparator | Other: 0.9% Saline with glucose 5%rate of infusion is 125cc/h |
| Ringer lactate | Active comparator | Other: Ringer lactaterate of infusion is 250cc/h |
| Ringer lactate - Controls | Active comparator | Other: Ringer lactate - Controlsrate of infusion is 125cc/h |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Nulliparous women
- Gestational age 37-41 weeks
- Cervical dilatation 1-3 cm
- Vertex presentation
- Singleton
Key exclusion criteria (6 listed)
- Diabetes
- Preeclampsia
- Intra uterine fetal growth restriction
- Duration of labor less than an hour
- Maternal chronic disease
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 |
|---|---|---|
| 0.9% Saline with glucose 5%intravenous hydration at a rate of 125 ml per hour during labor | Other | 0.9% Saline with glucose 5% |
| Ringer lactateintravenous hydration at a rate of 250 ml per hour during labor | Other | Ringer lactate |
| Ringer lactate - Controlsintravenous hydration at a rate of 125 ml per hour during labor | Other | Ringer lactate - Controls |
Primary outcome
Length of time from enrollment until delivery
Time frame: within the first 48 hours after delivery
2 secondary outcomes
Mode of delivery
Time frame: within the first 48 hours after delivery
Neonatal outcome
Time frame: within the first 48 hours after delivery
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 23 Feb 2016.
- Derived from this study: PubMed 28470550Garmi G, Zuarez-Easton S, Zafran N, Ohel I, Berkovich I, Salim R. The effect of type and volume of fluid hydration on labor duration of nulliparous women: a randomized controlled trial. Arch Gynecol Obstet. 2017 Jun;295(6):1407-1412. doi: 10.1007/s00404-017-4381-1. Epub 2017 May 3.
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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.
Raed Salim, MD principal investigator
Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% Saline with glucose 5% and Ringer lactate in people with Labor Stage, First and Labor Stage, Second, run by HaEmek Medical Center, Israel at 1 site 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 5 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: finished, as of the sponsor's last update on 23 Feb 2016. 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 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?
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?
Length of time from enrollment until delivery (time frame: within the first 48 hours after delivery). 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 NCT01242293, 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 23 Feb 2016.