Effect of Date Fruit Consumption in Later Pregnancy

Sponsor
Pak Emirates Military Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05105893
Collaborator
(none)
142
1
2
5.9
24

Study Details

Study Description

Brief Summary

EFFECT OF DATE FRUIT CONSUMPTION IN LATER PREGNANCY ON LENGTH OF GESTATION LABOR AND DELIVERY OF NULLIPAROUS WOMEN

Condition or Disease Intervention/Treatment Phase
  • Other: Dates group
N/A

Detailed Description

This randomized, controlled study was conducted at the Gynecology and Obstetrics department of Pak Emirates Military Hospital for Six months duration from Jan 2021 to June 2021. Ethical consent for the study was taken from the Ethical Committee. All participants have signed the written consent. Healthy primigravida's at more than 37 weeks of gestation with no prenatal complications (low-risk pregnancies) or chronic diseases were invited to contribute in the analysis.

The criteria of exclusion included all primigravida and non-primigravida with prenatal problems. Prenatal complications included placenta praevia, rupture of membranes, multiple pregnancies, diabetes, hypertension and additional health problems, fetal abnormalities, fetal growth restriction or any contraindication to delivery by vagina.

The females who met the eligibility criteria were contacted and provided information related to the analysis. In the preliminary phase of contact with potential volunteers, the study was presented as a participant's usage of dates to expedite delivery. The randomization arrangement was performed by means of sealed envelopes numbered from 1 to 10, equally allocated by randomization to the date-consumers and the group of control. Therefore, they will be allocated to dates consumer or control group recipients.

Study Design

Study Type:
Interventional
Actual Enrollment :
142 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Date Fruit Consumption in Later Pregnancy on Length of Gestation Labor and Delivery of Nulliparous Women
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Dates group

The experimental group of women was given several dates orally and instructed to take seven a day and record their consumption until the beginning of the active phase of labor. Seven pieces of dates are about 80g of daily consumption

Other: Dates group
Seven dates to be provided to patients

Other: No dates

This group wasnt provided dates.

Other: Dates group
Seven dates to be provided to patients

Outcome Measures

Primary Outcome Measures

  1. Effect of date fruit consumption in later pregnancy on length of gestation [6 months]

    Effect of Intake of dates in later pregnancy on the period of gestation in weeks

  2. Effect of date fruit consumption in later pregnancy on labour and delivery [6 months]

    To know the effect of dates intake on onset of labour whether it enhances the spontaneous onset of labour, avoiding any induction of labour and the time of 1st and 2nd stage of labour (in hours)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All primigravidas at 37 or more weeks gestation with low risk pregnancies
Exclusion Criteria:
  • Any antenatal complications Preterm pregnancies

Contacts and Locations

Locations

Site City State Country Postal Code
1 PEMH Rawalpindi Punjab Pakistan 44000

Sponsors and Collaborators

  • Pak Emirates Military Hospital

Investigators

  • Principal Investigator: Salma Nisar, Resident

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Salma Nisar, Resident OBGYN, Pak Emirates Military Hospital
ClinicalTrials.gov Identifier:
NCT05105893
Other Study ID Numbers:
  • 13102021
First Posted:
Nov 3, 2021
Last Update Posted:
Nov 3, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Salma Nisar, Resident OBGYN, Pak Emirates Military Hospital

Study Results

No Results Posted as of Nov 3, 2021