NCT03191877

Brief Summary

Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To measure the effect of coffee consumption on intestinal motility after caesarean section for the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary outcome and secondary outcome will be measured.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

January 9, 2018

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

June 9, 2017

Last Update Submit

January 8, 2018

Conditions

Gastrointestinal Motility

Keywords

coffee consumptionCesarean sectionintestinal motility

Outcome Measures

Primary Outcomes (1)

  • passage of stool.

    passage of stool within 72 hours. (time to be recorded by 24-hour clock from finishing of surgery)

    72 hours

Secondary Outcomes (9)

  • Passage of flatus. . The amount of analgesia. The first Breastfeeding time. The initiation of Mobilization. Hospital length stay.

    72 hours

  • Audible intestinal sound time.

    72 hours

  • Feeding time

    72 hours

  • Pain scale by VAS (Visual Analogue Scale ).

    72 hours

  • Type of analgesia needed.

    72 hours

  • +4 more secondary outcomes

Study Arms (3)

COFFEE

EXPERIMENTAL

they will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound.

Dietary Supplement: coffee

oral fluid

ACTIVE COMPARATOR

they will drink plain fluid (water) 6 hours postoperative. Diet will start after 1st audible bowel sound. Women in this group will not receive either coffee.

Dietary Supplement: coffee

control

NO INTERVENTION

the control group and they will be NPO for 24 hours on IV fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound

Interventions

coffeeDIETARY_SUPPLEMENT

Nescafe "brand of coffee made by Nestlé", red mug 100 % pure coffee 12083811

COFFEEoral fluid

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elective caesarian section, singleton pregnancy, term, viable fetus

You may not qualify if:

  • medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFHSR

Khamis Mushait, Abha, 16757, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mufareh Asiri, SBOG

    Postpartum ward of Armed Forces Hospital, Southern Region. Khamis Mushait, Asir, Saudi Arabia, 101

    STUDY CHAIR

Central Study Contacts

Mufareh Asiri, SBOG

CONTACT

00966553725252dr.mufareh@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OB/GYN REGISTRAR

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 19, 2017

Study Start

January 9, 2018

Primary Completion

May 30, 2018

Study Completion

June 30, 2018

Last Updated

January 9, 2018

Record last verified: 2017-06

Locations

SA(1)