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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03276741
Other study ID # FDG20170006H
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 29, 2017
Est. completion date January 11, 2020

Study information

Verified date April 2020
Source David Grant U.S. Air Force Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized clinical trial (RCT) to evaluate the impact of unrestricted low fat, low residue oral intake during labor on maternal and neonatal outcomes as well as maternal satisfaction.


Description:

This study is a quantitative, randomized experimental design study to determine the impact of unrestricted low fat, low residue oral intake during labor on the indicated outcome variables and patient satisfaction. The comparison group will continue standard care of being allowed a clear liquid during active labor (≥6cm dilation), while the experimental group would be allowed to self-regulate oral intake with a low fat, low residue diet during active labor.


Recruitment information / eligibility

Status Terminated
Enrollment 126
Est. completion date January 11, 2020
Est. primary completion date January 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Active Duty and Department of Defense (DoD) beneficiary Pregnant women 18 years of age and older

- 37 weeks gestation or greater at time of admission

- singleton fetus

- cephalic presentation

- who plan to labor/deliver at DGMC (military beneficiaries).

Exclusion Criteria:

- Morbid/severe obesity (pre-pregnancy BMI =40 kg/m2

- diabetes

- hypertension (to include pre-eclampsia or eclampsia)

- previous cesarean section

- uncontrolled gastroesophageal reflux disease (GERD) (symptomatic with medication)

- past history or current diagnosis of hyperemesis gravidarum

- food allergies to any items contained in the gastric/soft bland diet

- patients utilizing nitrous oxide for labor analgesia (should this treatment be available at DGMC)

- Difficult airway as defined by the anesthesia staff.

- Mallampati score 3 or 4

- Thyroid mental distance less than 7 cm or 3 finger breaths

- Mouth opening less than 3 finger breaths

- Short thick neck, Micrognathia

- Further indications as determined by the anesthesia provider doing the anesthesia preoperative assessment (pregnancy in and of itself will not be considered a disqualification due to airway changes during labor)" in order to define difficult airway per anesthesia.

- Under age 18

- Additional clinical risk factors as determined by the care provider

Study Design


Intervention

Dietary Supplement:
gastric soft/bland diet
Patients in the experimental group will have a gastric soft/bland diet available.

Locations

Country Name City State
United States USAF David Grant Medical Center Travis Air Force Base California

Sponsors (1)

Lead Sponsor Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nausea # episodes active labor (6cm or greater dilation) through delivery of the infant
Primary Vomiting # episodes active labor (6cm or greater dilation) through delivery of the infant
Primary Duration of labor #hours/minutes active labor (6cm or greater dilation) through delivery of the infant
Primary Mode of delivery cesarean section, operative vaginal delivery, spontaneous vaginal delivery at birth
Primary Aspiration # episodes active labor (6cm or greater dilation) through delivery of the infant
Primary Newborn APGAR Score < 7 5 min of life
Primary Maternal Satisfaction open ended survey question active labor (6cm or greater dilation) through delivery of the infant
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