Labor and DeliveryNCT03949166
Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome
A study testing food during labor and delivery in people with Labor and Delivery, run by Meir Medical Center at 1 site in Israel.
Trial summary
The recommendations regarding eating and drinking during the labor and delivery process are not clear. The objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor and Delivery
- What is being tested?
- food during labor and delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Dec 2018to 1 Feb 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy at 37 weeks or more
- After an epidural anaesthesia
Who cannot join
- Preterm delivery before 37 weeks of pregnancy
- Known anomalies or chromosomal abnormalities
- Patient at increased risk for aspiration based on anesthesiologist assesment
- A patient post epidural anesthesia with pain indicating the need for a new epidural insertion
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meor Medical hospital
Kfar Saba, 4428164
Shanny Hadar, 97297471588, shanny.hadar@clalit.org.il
About this study
The recommendations regarding eating and drinking during the labor and delivery process are not clear.
The objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.
Read more
Patients admitted for the birthing center during the first stage of the delivery and after having a regional anesthesia are instructed as a routine in our birthing center for fasting and drinking only water and clear fluids during their stay at the labor and delivery room and until after giving birth.
The patients will be asked if they are interested in participating in the study. A patient that is interested will be randomized to join one of the two arms: Fasting arm, with the routine management of water and clear fluids or eating, she will be asked to eat every 2 hours or less a food from a list supplied by the study team.
The list of food was created with the anesthesiologist team according the review board demand.
The data regarding the patients' history, pregnancy and labor and delivery process. Obstetrical and neonatal outcome will be collected. A satisfactory questioner well be sent to all participants.
Read the detailed description
Vaginal birth can be a prolonged process, especially during the first delivery. The recommendations regarding eating and drinking during the labor and delivery process are not clear. There is no agreement between the physicians regarding eating and drinking while being in labor in the birthing center. This disagreement is due to lack of research in this field and inconclusive results in previous studies.
Prolonged fasting during labor can lead to execution of the patients making them tired and less tolerant to the pain, decreasing their ability to cooperate during the pushing phase. However, the recommendation to avoid eating has justified by the risk for unplanned cesarean section which is done under fasting. In general, cesarean sections are done under regional anesthesia but if there is a need for general anesthesia (due to pain or urgency), there is a risk for aspiration if the patient has not been fasting.
We also know that the stomach is clearing slower in the labor process, therefore some recommend fasting during labor.
In recent years there is a decrease in the use of general anesthesia during cesarean sections and since the incidence of aspiration during cesarean section is rare and due to the demand from the patients for autonomy and controlling their labor process including the option of eating the debate regarding eating during labor and delivery is justified.
In 2009 an ACOG(American College of Obstetricians and Gynecologists ) committee report concluded that there is not enough evidence regarding the link between drinking clear fluids and reflux , vomiting and aspiration during labor.
the objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.
Patients admitted for the birthing center during the first stage of the delivery and after having a regional anesthesia are instructed as a routine in our birthing center for fasting and drinking only water and clear fluids during their stay at the labor and delivery room and until after giving birth.
The patients will be asked if they are interested in participating in the study. A patient that is interested will be randomized to join one of the two arms:
- Fasting arm- The patient will be allowed to drink water and clear fluids as the routine management in our birthing center
- Eating arm - The patient will be asked to eat every 2 hours or less a food from a list supplied by the study team, with no limitations on drinking.
The list of food was created with the anesthesiologist team according the review board demand.
The data regarding the patients' history, pregnancy and labor and delivery process. Obstetrical and neonatal outcome will be collected. A satisfactory questioner well be sent to all participants.
- Conditions
- Labor and Delivery
- Being tested
- food during labor and delivery
- Keywords
- labor, delivery, eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food during labor and deliveryOther
The food that will be allowed during labor and delivery was approved by the anesthesia team. It includes - fruits, energy bars, yogurt,
| Study group | Role | What they receive |
|---|---|---|
| Fasting | No intervention | After completion of an epidural block patients that agreed to participate in the study and were randomised to the fasting arm will be allowed to drink water and clear fluids during labor and delivery as accepted by the institute protocol. |
| Eating | Experimental | After completion of an epidural block patients that agreed to participate in the study and were randomized to the eating arm will be allowed to eat during their labor and delivery. They will be provided with the list of food that was approved and accepted by the anesthesia team. They will be asked to try eating every 2 hours but if they feel lack of need to eat or any side effects preventing them to eat they can choose not to eat. When reaching full dilatation of 10cm they will ber asked to stop eating. Receives: Other: food during labor and delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
prolonged second stage of labor
The mean time from full dilatation to the delivery of the baby on each group
Measured: the delivery
duration of pushing
The mean time from beginning of pushing with the midwife to the delivery of the baby in each group
Measured: the delivery
operative vaginal delivery
The mean incidence of operative vaginal delivery in each group
Measured: the delivery
cesarean section
The mean incidence of cesarean section in each group
Measured: the delivery
Secondary outcomes (1)
Maternal satisfaction
The median satisfaction from the delivery of the mother of the delivery process from 1-11
Measured: from 2 days after delivery until 6 months after the delivery , she will be asked once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start18 Dec 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor and DeliveryStudies 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
- There are 2 arms - fasting and eating
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil Shechter Maor, MD, Principal investigator, Meir Medical hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949166
- Sponsor's protocol ID
- MMC19-0258-17CTIL
- Status last verified
- Nov 2019
- First submitted
- 12 May 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome
- ClinicalTrials.gov ID
- NCT03949166
- Acronym / sponsor ID
- MMC19-0258-17CTIL
- Conditions
- Labor and Delivery
- Keywords
- labor, delivery, eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 14 May 2019 (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.
The recommendations regarding eating and drinking during the labor and delivery process are not clear.
The objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.
Patients admitted for the birthing center during the first stage of the delivery and after having a regional anesthesia are instructed as a routine in our birthing center for fasting and drinking only water and clear fluids during their stay at the labor and delivery room and until after giving birth.
The patients will be asked if they are interested in participating in the study. A patient that is interested will be randomized to join one of the two arms: Fasting arm, with the routine management of water and clear fluids or eating, she will be asked to eat every 2 hours or less a food from a list supplied by the study team.
The list of food was created with the anesthesiologist team according the review board demand.
The data regarding the patients' history, pregnancy and labor and delivery process. Obstetrical and neonatal outcome will be collected. A satisfactory questioner well be sent to all participants.
Detailed description
Vaginal birth can be a prolonged process, especially during the first delivery. The recommendations regarding eating and drinking during the labor and delivery process are not clear. There is no agreement between the physicians regarding eating and drinking while being in labor in the birthing center. This disagreement is due to lack of research in this field and inconclusive results in previous studies.
Prolonged fasting during labor can lead to execution of the patients making them tired and less tolerant to the pain, decreasing their ability to cooperate during the pushing phase. However, the recommendation to avoid eating has justified by the risk for unplanned cesarean section which is done under fasting. In general, cesarean sections are done under regional anesthesia but if there is a need for general anesthesia (due to pain or urgency), there is a risk for aspiration if the patient has not been fasting.
We also know that the stomach is clearing slower in the labor process, therefore some recommend fasting during labor.
In recent years there is a decrease in the use of general anesthesia during cesarean sections and since the incidence of aspiration during cesarean section is rare and due to the demand from the patients for autonomy and controlling their labor process including the option of eating the debate regarding eating during labor and delivery is justified.
In 2009 an ACOG(American College of Obstetricians and Gynecologists ) committee report concluded that there is not enough evidence regarding the link between drinking clear fluids and reflux , vomiting and aspiration during labor.
the objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.
Patients admitted for the birthing center during the first stage of the delivery and after having a regional anesthesia are instructed as a routine in our birthing center for fasting and drinking only water and clear fluids during their stay at the labor and delivery room and until after giving birth.
The patients will be asked if they are interested in participating in the study. A patient that is interested will be randomized to join one of the two arms:
- Fasting arm- The patient will be allowed to drink water and clear fluids as the routine management in our birthing center
- Eating arm - The patient will be asked to eat every 2 hours or less a food from a list supplied by the study team, with no limitations on drinking.
The list of food was created with the anesthesiologist team according the review board demand.
The data regarding the patients' history, pregnancy and labor and delivery process. Obstetrical and neonatal outcome will be collected. A satisfactory questioner well be sent to all participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 arms - fasting and eating
| Arm | Type | Receives |
|---|---|---|
| Fasting | No intervention | –After completion of an epidural block patients that agreed to participate in the study and were randomised to the fasting arm will be allowed to drink water and clear fluids during labor and delivery as accepted by the institute protocol. |
| Eating | Experimental | Other: food during labor and deliveryAfter completion of an epidural block patients that agreed to participate in the study and were randomized to the eating arm will be allowed to eat during their labor and delivery. They will be provided with the list of food that was approved and accepted by the anesthesia team. They will be asked to try eating every 2 hours but if they feel lack of need to eat or any side effects preventing them to eat they can choose not to eat. When reaching full dilatation of 10cm they will ber asked to stop eating. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnancy at 37 weeks or more
- After an epidural anaesthesia
Key exclusion criteria (4 listed)
- Preterm delivery before 37 weeks of pregnancy
- Known anomalies or chromosomal abnormalities
- Patient at increased risk for aspiration based on anesthesiologist assesment
- A patient post epidural anesthesia with pain indicating the need for a new epidural insertion
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 |
|---|---|---|
| food during labor and deliveryThe food that will be allowed during labor and delivery was approved by the anesthesia team. It includes - fruits, energy bars, yogurt, | Other | Eating |
Primary outcome
prolonged second stage of labor
Time frame: the delivery
The mean time from full dilatation to the delivery of the baby on each group
duration of pushing
Time frame: the delivery
The mean time from beginning of pushing with the midwife to the delivery of the baby in each group
operative vaginal delivery
Time frame: the delivery
The mean incidence of operative vaginal delivery in each group
cesarean section
Time frame: the delivery
The mean incidence of cesarean section in each group
1 secondary outcome
Maternal satisfaction
Time frame: from 2 days after delivery until 6 months after the delivery , she will be asked once
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
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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.
Gil Shechter Maor, MD principal investigator
Meir Medical hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food during labor and delivery in people with Labor and Delivery, run by Meir Medical Center 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 2 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 29 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gil Shechter Maor, MD (972/543591626, gilshec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prolonged second stage of labor (time frame: the delivery). The study lists 4 primary outcomes in all. 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 29 Nov 2019.