Effect of Date Fruit Consumption in Later Pregnancy

Effect of Date Fruit Consumption in Later Pregnancy on Length of Gestation Labor and Delivery of Nulliparous Women

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

Study Overview

• Status: Completed
• Conditions: Labor Long
• Intervention / Treatment: Other: Dates group

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 44000
      • PEMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All primigravidas at 37 or more weeks gestation with low risk pregnancies

Exclusion Criteria:

• Any antenatal complications Preterm pregnancies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of date fruit consumption in later pregnancy on length of gestation	Effect of Intake of dates in later pregnancy on the period of gestation in weeks	6 months
Effect of date fruit consumption in later pregnancy on labour and delivery	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)	6 months

Collaborators and Investigators

• Sponsor: Pak Emirates Military Hospital
• Investigators: Principal Investigator: Salma Nisar, Resident

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: delivery; Dates; labour; period of gestation
• Other Study ID Numbers: 13102021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No