The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding

NCT04441125 | Completed

• 1 other identifier: 76
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This study has been planned as an observational study. The aim of this study is to determine the effect of labor induction with oxytocin on early postpartum hemorrhage, perineal integrity and breastfeeding. Materials and Methods: The sample consists of 88 healthy mother and infant pairs. The mothers in the case group will receive oxytocin induction before and after delivery. On the other hand, the mothers in the control group will not receive any oxytocin induction before delivery, and will receive oxytocin induction in the end of delivery. Data were collected by using the Personal Information Form, the LATCH Breastfeeding Diagnostic Scale, the Breastfeeding Self-Efficacy Scale, the follow-up bag for postpartum hemorrhage, and episiotomy healing assessment known as the REEDA Scale.

Conditions

Oxytocin

Keywords

Breastfeeding; Perineal Integrity; Postpartum Hemorrhage; oxytocin

Outcome Measures

Primary Outcomes (4)

• The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)

  Assessment is made by giving 0, 1, 2 and 3 scores to each title in the scale, and 0 is the lowest score and 15 is the highest score. 0 is the normal value for total score. In the scale, an increase in score indicates that there is pathology, and a decrease in score indicates that there is a recovery. The REEDA score is evaluated in the 12th hour after delivery.

  12th hour

• The Breastfeeding Self-Efficacy Scale(BSES)

  This form is a five-point Likert-type scale, and it is scored as follows: "1=not at all confident", "2=not very confident", "3=sometimes confident", "4=confidentˮ, "5=very confidentˮ. The Breastfeeding Self-Efficacy Scale consists of 14 items. The lowest score which can be achieved from the scale is 14, and the highest score is 70. Achieving a high score indicates that the mothers have a high breastfeeding self-efficacy. The Breastfeeding Self-Efficacy is evaluated in the 24th hour after delivery.

  24th hour

• L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni

  The LATCH: It consists of five evaluation criteria. Each item is evaluated between the score range of "0 - 2ˮ. In the scale, the highest score which can be achieved is 10, and the lowest score is 0. As the score achieved from this scale increases, the success in breastfeeding increases. The LATCH score is evaluated in the 24th hour after delivery.

  24th hour

• The Follow-up Bag for Postpartum Hemorrhage(postpartum blood bag +pad weigth )

  The postpartum hemorrhage bag has been calibrated in order to help for the follow-up of vaginal hemorrhage and fluid, and has been designed as filtration-specific. The bag is transparent colored, and the amount within the bag is recorded as milliliter.The postpartum hemorrhage bag is placed under the mother's perineal region after the delivery in order to measure the postpartum hemorrhage, and the amount of hemorrhage is recorded when the mother leaves the gynecological table. Then, the hemorrhage follow-up is made through a pad when the mother is taken to the bed. All pads are sterile and same in size. In the 24th postpartum hour, the pads used by the researcher are weighed and recorded.

  24th hour

Secondary Outcomes (3)

• The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)

  24th hour

• The Breastfeeding Self-Efficacy Scale(BSES)

  The first week

• L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni

  The first week

Study Arms (2)

case group

The mothers in the case group will receive oxytocin induction before and after delivery(n:44).

control group

The mothers in the control group will not receive any oxytocin induction before delivery, and will receive oxytocin induction in the end of delivery(n:44)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women aged 18-35 years, having a single pregnancy, literate, between 37-42 gestational week, hemoglobin level of 10 g and above, without chronic, mental and psychological disease were included in the study. Infants without congenital anomalies, with a first Apgar score of 8 and above, birth weight between 2500- 4000 g and no obstruction to oral feeding constituted the sample of the study.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study consists of the primiparous pregnant women who comply with the study criteria, accept the study, and who are hospitalized in the delivery unit at Zeynep Kamil Women and Children Diseases Training and Research Hospital

You may qualify if:

• Women aged 18-35 years,
• having a single pregnancy,
• literate,
• between 37-42 gestational week,
• hemoglobin level of 10 g and above,
• without chronic, mental and psychological disease
• Infants;
• without congenital anomalies,
• with a first Apgar score of 8 and above,
• birth weight between 2500 - 4000 g
• no obstruction to oral feeding

You may not qualify if:

• multiparity,
• any risky condition development in the mother and baby during or after birth

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• Kartal YA, Kaya L, Yazici S. Effects of oxytocin induction on early postpartum hemorrhage, perineal integrity, and breastfeeding: a case-control study. Rev Assoc Med Bras (1992). 2023 Dec 22;70(1):e20231002. doi: 10.1590/1806-9282.20231002. eCollection 2023.

  PMID: 38126414 DERIVED

MeSH Terms

Conditions

Breast Feeding; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; 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

Study Officials

• YASEMİN AYDIN KARTAL, PhD

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: June 1, 2019
• Primary Completion: August 15, 2020
• Study Completion: September 20, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)