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Date Consumption and Uterine Involution

S

Sakarya University

Status

Unknown

Conditions

Uterus Involution
Early Postpartum Hemorrhage

Treatments

Dietary Supplement: Date Fruit

Study type

Interventional

Funder types

Other

Identifiers

NCT05072769
48535046780

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

10 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Experimental group
Experimental group
Description:
After the fetus and placenta are born, feeding 100 gr (5-6 pieces) dates to the experimental group
Treatment:
Dietary Supplement: Date Fruit
Control group
No Intervention group
Description:
The group that was not attempted any intervention in the postpartum period

Trial contacts and locations

1

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Central trial contact

Yasemin Hamlacı Başkaya, Dr; Kevser Özdemir, Dr

Data sourced from clinicaltrials.gov

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