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

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.

Study Overview

• Status: Completed
• Conditions: Oxytocin

Detailed Description

Oxytocin is applied to the women in the case group before the delivery.

There is a procedure on the usage of oxytocin at the delivery room. In accordance with the relevant procedure, it is administered as an intravenous infusion by adding 5 units of oxytocin in 500 cc of physiological saline solution.

The initial dosage is adjusted in order to allow for the flow of 4 drops per minute. Maximum 40 drops in total can be applied by increasing for 4 drops every 20 minutes. The dosage can be increased by considering the intensity and duration of contractions. The initial dosage of the oxytocin procedure applied to the women is the same for all women. As the total duration of delivery is different, there are differences between the dosages of oxytocin received.

In accordance with the postpartum procedure at the delivery room, it is administered as an intravenous infusion to all women (primiparous, multiparous) by adding 20 units of oxytocin in 500 cc of physiological saline solution immediately after the delivery.

The women in the control group do not receive any oxytocin induction before the delivery, and these women give birth spontaneously. After the delivery, the postpartum procedure applied for the control group is preferred.

Episiotomy is applied routinely to the primiparous pregnant women at the gynecological examination table in order to enlarge the opening of the vagina during the delivery. Episiotomy is a surgical incision applied to the bulbo-cavernous muscle in the perineal region while the baby's head appears in order to protect the perineal tonus, prevent undesired repairs, and to provide an easy, quick and safe delivery by enlarging the vaginal opening. Medio-lateral episiotomy is applied routinely to all women.

Immediately after the delivery, the baby's umbilical cord is clamped and cut. The postpartum hemorrhage bag is placed under the mother's perineal region immediately after the umbilical cord is cut, and it is waited for separation of the placenta. The duration for separation of the placenta is 30 minutes in maximum. After separation of the placenta, episiotomy repair is made. The loss of blood in the postpartum hemorrhage bag is recorded after the episiotomy repair. Before the woman is taken to her bed, necessary pads are provided, postpartum hemorrhage is followed-up, and the pads are weighed in the 24th postpartum hour.

The perineal region is evaluated by the REEDA scale in the postpartum 12th hour and the

The LATCH, the Breastfeeding Assessment, and the BSES are applied in the postpartum 24th hour and the first week.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34668
    • Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 24th hour after delivery.	24th 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 first week after delivery.	The first week
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 first week after delivery.	The first week

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Study Director: YASEMİN AYDIN KARTAL, PhD, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): September 20, 2020

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: oxytocin; Postpartum Hemorrhage; Breastfeeding; Perineal Integrity
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No