Date Consumption and Uterine Involution

NCT05072769 | Unknown

• 1 other identifier: 48535046780
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterus Involution; Early Postpartum Hemorrhage

Keywords

birth; date fruit; oxytocin; uterus involution

Outcome Measures

Primary Outcomes (3)

• Hemoglobin values

  Approximately 500 ml of blood is lost in vaginal delivery. Blood loss exceeding 500 ml in the postpartum period is a sign of bleeding. therefore, the involution process will be defined with the changes in hemoglobin (gr/dl) immediately after birth and 6 hours after birth.

  6 hours

• Hematocrit values

  More than 10% decrease in the postpartum period compared to the prenatal period indicates bleeding. Therefore, the hematocrit (gr/dl) changes immediately after birth and 6 hours after birth will define the involution process.

  6 hours

• Oxytocin values

  Oxytocin, which is produced in the hypothalamus and enters the circulation from the posterior pituitary, is a hormone that prevents postpartum hemorrhage by regulating the intensity and rhythm of postpartum uterine contractions. For this reason, the involution process will be defined by looking at oxytocin releases immediately after birth and 6 hours after birth.

  6 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Dietary Supplement: Date Fruit

Control group

NO INTERVENTION

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

Interventions

Date Fruit DIETARY_SUPPLEMENT

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

Experimental group

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28286995 RESULT

• 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.

  PMID: 21280989 RESULT

• 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.

  PMID: 29033994 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Chronology as Topic

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Time; Physical Phenomena

Study Officials

• Kevser Özdemir, Dr

  Sakarya University

  STUDY CHAIR

Central Study Contacts

Kevser Özdemir, Dr

CONTACT

+90 264 295 66 24; kevserozdemir@sakarya.edu.tr

Yasemin Hamlacı Başkaya, Dr

CONTACT

+90 295 295 43 31; yhamlaci@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no need for masking as placebo will not be applied.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: There will be an experimental and a control group. Dates will be given to the experimental group after the birth, while the control group will be treated in line with the hospital routines.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 11, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be collected in the first hour and sixth hour after patients give birth. It will be reported after reaching the entire sample group.
• Access Criteria: The data obtained from the study will be shared after it is reported and published.

Locations

TU (1)