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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05105893
Other study ID # 13102021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date June 30, 2021

Study information

Verified date October 2021
Source Pak Emirates Military Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - All primigravidas at 37 or more weeks gestation with low risk pregnancies Exclusion Criteria: - Any antenatal complications Preterm pregnancies

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dates group
Seven dates to be provided to patients

Locations

Country Name City State
Pakistan PEMH Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Pak Emirates Military Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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