Date Consumption and Uterine Involution

NCT ID: NCT05072769

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-07-01

Brief Summary

There are many studies in the literature examining the effects of dates on pregnancy, birth and postpartum processes. However, no study has been found that examines the effect of women on the involution process in the early postpartum period. It is thought that this study will fill the gap in the literature with this study, which was conducted to determine the effect of date fed to women in the early postpartum period on uterine involution.

The study was planned as a randomized controlled and experimental study to determine the effect of date fed to women in the early postpartum period on uterine involution.

It will be held in the postpartum service of Sakarya University Training and Research Hospital between October - April 2021.

Detailed Description

There are many studies in the literature examining the effects of dates on pregnancy, birth and postpartum processes. However, no study has been found that examines the effect of women on the involution process in the early postpartum period. It is thought that this study will fill the gap in the literature with this study, which was conducted to determine the effect of date fed to women in the early postpartum period on uterine involution.

The study was planned as a randomized controlled and experimental study to determine the effect of date fed to women in the early postpartum period on uterine involution.

It will be held in Sakarya University Training and Research Hospital delivery room and postpartum service between October - December 2021.

The universe of the study will be women who gave vaginal birth between October and December 2021 in the delivery room and puerperal service department of Sakarya University Training and Research Hospital, and the sample will be 60 women (30 experimental group-30 control group).

Which of the women forming the sample group will be included in the experimental/intervention and control groups will be determined by simple randomization. A "random number generation program (research randomizer)" will be used in the randomization of the sample, and randomization with this program will be done by an unbiased researcher who is not involved in the research.

The implementation phase of the research will start after the third stage of labor (after the fetus and its appendages are born) ends. After the mother is stabilized, the "Descriptive Demographic Information Form" will be filled in for the experimental and control groups, and then blood samples will be taken from the mothers in order to determine the hemoglobin, hematocrit and oxytocin values. Since the blood sample will be taken from the intravenous line opened for emergencies during labor, an additional invasive procedure will not be applied to the patients. After the first blood sample is taken, 100gr (5-6 pieces) of Deglet Noor dates will be given to the experimental group and asked to be consumed within one hour. At this stage, the practices will continue in accordance with the hospital routines for the mothers in the control group. At the 6th hour after the third stage of labor, blood samples will be taken again to determine the hemoglobin, hematocrit and oxytocin values, and the application will end. In the postpartum ward, where the study will be conducted, routine blood samples are taken at the 6th hour after birth, so invasive intervention will be avoided.

Conditions

Uterus Involution; Early Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental group

After the fetus and placenta are born, feeding 100 gr (5-6 pieces) dates to the experimental group

Group Type: EXPERIMENTAL

Date Fruit

Intervention Type: DIETARY_SUPPLEMENT

Within the first hour after birth, 100gr (5-6 pieces) dates will be eaten.

Control group

The group that was not attempted any intervention in the postpartum period

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Date Fruit

Within the first hour after birth, 100gr (5-6 pieces) dates will be eaten.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Volunteer to participate in the research,
• Primiparous,
• Not induction during birth,
• Born at term and healthy (38-42 weeks old, born 2500-4000gr, born with 5th minute apgar 7 and above, no known congenital disease),
• Not given oxytocin in the postpartum period,
• No oral intake restriction after controlling for postpartum uterine involution,
• Over 18 years of age who gave vaginal birth,
• It is planned to include mothers who can speak Turkish.

Exclusion Criteria

• Not willing to participate in the research,
• Risk of postpartum bleeding in the first hour after delivery,
• Having a health problem in which the mother or baby is at risk,
• Not breastfeeding her baby
• Having a disease that prevents breastfeeding,
• Those whose hemoglobin value is below 10 g/dl,
• Cesarean delivery,
• Have a blood disease,
• The baby was taken to the neonatal intensive care unit,
• It is planned not to include mothers with diabetes.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kevser Ozdemir

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevser Özdemir, Dr

Role: STUDY_CHAIR

Sakarya University

Locations

Sakarya University

Sakarya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Kevser Özdemir, Dr

Role: CONTACT

kevserozdemir@sakarya.edu.tr

+90 264 295 66 24

Yasemin Hamlacı Başkaya, Dr

Role: CONTACT

yhamlaci@sakarya.edu.tr

+90 295 295 43 31

Facility Contacts

Kevser Özdemir, Dr

Role: primary

kevserozdemir@sakarya.edu.tr

+90 264 295 66 24

References

Razali N, Mohd Nahwari SH, Sulaiman S, Hassan J. Date fruit consumption at term: Effect on length of gestation, labour and delivery. J Obstet Gynaecol. 2017 Jul;37(5):595-600. doi: 10.1080/01443615.2017.1283304. Epub 2017 Mar 13.

Reference Type: RESULT

PMID: 28286995 (View on PubMed)

Al-Kuran O, Al-Mehaisen L, Bawadi H, Beitawi S, Amarin Z. The effect of late pregnancy consumption of date fruit on labour and delivery. J Obstet Gynaecol. 2011;31(1):29-31. doi: 10.3109/01443615.2010.522267.

Reference Type: RESULT

PMID: 21280989 (View on PubMed)

Kordi M, Meybodi FA, Tara F, Fakari FR, Nemati M, Shakeri M. Effect of Dates in Late Pregnancy on the Duration of Labor in Nulliparous Women. Iran J Nurs Midwifery Res. 2017 Sep-Oct;22(5):383-387. doi: 10.4103/ijnmr.IJNMR_213_15.

Reference Type: RESULT

PMID: 29033994 (View on PubMed)

Other Identifiers

48535046780

Identifier Type: -

Identifier Source: org_study_id