Oxytocin Clinical Trial
Official title:
The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
NCT number | NCT04441125 |
Other study ID # | 76 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | September 20, 2020 |
Verified date | November 2021 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | September 20, 2020 |
Est. primary completion date | August 15, 2020 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Zeynep Kamil Women's and Children's Diseases Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi |
Turkey,
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 |
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