OxytocinNCT04441125
The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
An observational study of Oxytocin, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Oxytocin
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 20 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
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
Who may be able to join
- 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
Show all 11Show fewer
- Infants;
- without congenital anomalies,
- with a first Apgar score of 8 and above,
- birth weight between 2500 - 4000 g
- no obstruction to oral feeding
Who cannot join
- multiparity,
- any risky condition development in the mother and baby during or after birth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Istanbul, 34668
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Oxytocin
- Keywords
- Breastfeeding, Perineal Integrity, Postpartum Hemorrhage, oxytocin
- Medical subject headings
- Breast Feeding, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24th hour
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: The first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jun 2019
- Primary completion15 Aug 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OxytocinStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
- Investigators
- YASEMİN AYDIN KARTAL, PhD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441125
- Sponsor's protocol ID
- 76
- Status last verified
- Nov 2021
- First submitted
- 16 Jun 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38126414
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
- ClinicalTrials.gov ID
- NCT04441125
- Acronym / sponsor ID
- 76
- Conditions
- Oxytocin
- Keywords
- Breastfeeding, Perineal Integrity, Postpartum Hemorrhage, oxytocin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (11 listed)
- Women aged 18-35 years,
- having a single pregnancy,
- literate,
- between 37-42 gestational week,
- hemoglobin level of 10 g and above,
Key exclusion criteria (2 listed)
- multiparity,
- any risky condition development in the mother and baby during or after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)
Time frame: 12th hour
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.
The Breastfeeding Self-Efficacy Scale(BSES)
Time frame: 24th hour
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.
L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni
Time frame: 24th hour
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.
The Follow-up Bag for Postpartum Hemorrhage(postpartum blood bag +pad weigth )
Time frame: 24th hour
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.
3 secondary outcomes
The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)
Time frame: 24th hour
The Breastfeeding Self-Efficacy Scale(BSES)
Time frame: The first week
L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni
Time frame: The first week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Derived from this study: PubMed 38126414Kartal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YASEMİN AYDIN KARTAL, PhD study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxytocin, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation) (time frame: 12th hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04441125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.