The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
NCT ID: NCT04441125
Last Updated: 2021-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
88 participants
OBSERVATIONAL
2019-06-01
2020-09-20
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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case group
The mothers in the case group will receive oxytocin induction before and after delivery(n:44).
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* any risky condition development in the mother and baby during or after birth
18 Years
35 Years
FEMALE
No
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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YASEMİN AYDIN KARTAL
Associate professor
Principal Investigators
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YASEMİN AYDIN KARTAL, PhD
Role: STUDY_DIRECTOR
Saglik Bilimleri Universitesi
Locations
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Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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76
Identifier Type: -
Identifier Source: org_study_id