Oral Intake During Labor

Satisfaction Clinical Trial

Official title:

Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03276741
• Other study ID #: FDG20170006H
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Complication of Anesthesia
• Food Aspiration
• Labor Complication
• Obstetric Labor Complications
• Satisfaction

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