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

Oxytocin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441125
• Other study ID #: 76
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: September 20, 2020

Study information

• Verified date: November 2021
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 20, 2020
• Est. primary completion date: August 15, 2020
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Oxytocin
• Postpartum Hemorrhage

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Women's and Children's Diseases Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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=confident?, "5=very confident?.; 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
Primary	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 - 2?. 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
Primary	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	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
Secondary	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=confident?, "5=very confident?.; 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
Secondary	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 - 2?. 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