Clinical trial NCT04441125: The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
Official title: The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxytocin
Keywords: Breastfeeding
Perineal Integrity
Postpartum Hemorrhage
oxytocin
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)
timeFrame: 12th hour
measure: The Breastfeeding Self-Efficacy Scale(BSES)
timeFrame: 24th hour
measure: L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni
timeFrame: 24th hour
measure: The Follow-up Bag for Postpartum Hemorrhage(postpartum blood bag +pad weigth )
timeFrame: 24th hour
Secondary outcomes:
measure: The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)
timeFrame: 24th hour
measure: The Breastfeeding Self-Efficacy Scale(BSES)
timeFrame: The first week
measure: L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni
timeFrame: The first week
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: YASEMİN AYDIN KARTAL, PhD
role: STUDY_DIRECTOR
References: