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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Routine care during labor (authorized clear liquid diet). | |
| Experimental Group | Active Comparator | Patients in the experimental group will have a gastric soft/bland diet available, which will include lean protein, fruits, vegetables, and low-fat dairy. This will be ordered in the electronic medical record (EMR) and is a standard "non-select meal," referred to as a gastric/soft bland diet that is not based on patient's preferred menu selections. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gastric soft/bland diet | Dietary Supplement | Patients in the experimental group will have a gastric soft/bland diet available. |
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| Measure | Description | Time Frame |
|---|---|---|
| Nausea | # episodes | active labor (6cm or greater dilation) through delivery of the infant |
| Vomiting | # episodes | active labor (6cm or greater dilation) through delivery of the infant |
| Duration of labor | #hours/minutes | active labor (6cm or greater dilation) through delivery of the infant |
| Mode of delivery | cesarean section, operative vaginal delivery, spontaneous vaginal delivery | at birth |
| Aspiration | # episodes | active labor (6cm or greater dilation) through delivery of the infant |
| Newborn APGAR Score | < 7 | 5 min of life |
| Maternal Satisfaction | open ended survey question | active labor (6cm or greater dilation) through delivery of the infant |
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Inclusion Criteria:
Exclusion Criteria:
Study includes pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Jeanette M Anderson, MSN | David Grant Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USAF David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2019 | Apr 10, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |
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quantitative, randomized experimental design study
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Personal identification removed (use of personal identification code)