The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding

NCT ID: NCT04425096

Last Updated: 2021-12-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2020-12-22

Brief Summary

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The aim of this study was to determine the effect of postpartum hemorrhage, pain and onset of early breastfeeding so that the skin applied at the third stage of birth is in contact with the skin. Material and Method: The study was carried out as a randomized controlled single-blind experimental study. The sample consists of 68 healthy mother and baby pairs. Skin contact with mothers and babies in the experimental group will be applied for 34 minutes immediately after birth. Routine care will be applied to the babies in the control group. Data will be collected using Personal Information Form, Visual Analogue Scale, LATCH Breastfeeding Diagnostic Scale, Breastfeeding Self-Efficacy Scale, postpartum hemorrhage follow-up bag, pad and oxytocin, ᵦ endorphine analysis results.

were collected using Personal Information Form, Visual Analogue Scale, LATCH Breastfeeding Diagnostic Scale, Breastfeeding Self-Efficacy Scale, postpartum bleeding follow-up bag, pad and oxytocin, ᵦ endorphin analysis results.

Detailed Description

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Implementation of the Practice of the Study; In the standard practice of the delivery room clinic, where the study was planned, babies are clamped as soon as they are born, and their routine care (such as K vit and hepatitis B vaccine application) is taken under the radiant heater. The skin contact can not be applied between the baby and the mother. After the baby is cared, until the mother is transferred to the postpartum clinic, the baby is wrapped in a clean cotton sterile cloth under a radiant heater in the baby room.

Routine care was applied to the babies of the control group mothers. No physical contact with the babies of the control group mothers was performed, standard applications were applied in the clinic (placing the baby under the radiant heater for clamping the umbilical cord as soon as it was born, K-vit application, Hepatitis B vaccine application etc.).

As soon as the babies of the mothers in the experimental group were born, the babies were placed in a prone position with skin contact on their mothers' bare belly. The baby was gently dried, covered with a blanket and a beret was worn. The umbilical cord of the baby was clamped late (approximately 1-3 minutes). The baby was kept in this position for 30 minutes and then taken under the radiant heater for routine care.

Blood was collected from women in the experimental and control groups for the 1st and 30th minutes after the birth of the baby for oxytocin and ᵦ endorphin analysis. After for both groups, VAS was applied after 2nd and 6th hours after birth, LATCH Breastfeeding Assessment and BSS were applied in 24th hour and 1 week later of the birth. Immediately after birth, a postpartum hemorrhage follow-up bag was placed on the gynecological table and followed by a bleeding bag until the mother got up from the gynecological table. When women were taken to bed from gynecological table, bleeding was followed up with a perineal pad. Weights of pad and mattress protections of women were weighed at 24 hours because normal women were discharged at 24 hours after delivery.

Conditions

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Skin to Skin Contact

Keywords

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Postpartum Pain Breastfeeding Beta Endorphin Oxytocin Postpartum Hemorrhage Skin to Skin Contact

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled single-blind experimental study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Skin to skin contact

The mothers and their babies in the experimental group received a 30-minute skin to skin contact immediately after birth (n:34)

Group Type EXPERIMENTAL

Skin to skin contact

Intervention Type OTHER

Skin to skin contact

Routine care

The babies in the control group received routine care (n:34)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Skin to skin contact

Skin to skin contact

Intervention Type OTHER

Eligibility Criteria

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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

* Induction practice,
* multiparity,
* any risky condition development in the mother and baby during or after birth
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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YASEMİN AYDIN KARTAL

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasemin AYDIN KARTAL, PhD

Role: STUDY_DIRECTOR

Saglık Bilimleri U

Locations

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Saglık Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Alus Tokat, M. & Okumuş, H. (2013). The Effect of Antenatal Training Based on Strengthening the Perception of Breastfeeding Self-Efficacy on the Perception of Breastfeeding Self- Efficacy and Breastfeeding. Journal of Nursing Education and Research, 10, 21-29

Reference Type BACKGROUND

Annagür, B. & Annagür, A. (2012). Relationship of Postpartum Mental Status with Breastfeeding. Current Approaches in Psychiatry, 4, 279-292

Reference Type BACKGROUND

Çalısır, H., Karaçam, Z., Akgül, F.A. & Kurnaz, D.A. (2009). Validity and Reliability of the Turkish Form of the Postpartum Parenting Behavior Scale. Journal of Atatürk University School of Nursing, 12, 1-8

Reference Type BACKGROUND

Cong X, Ludington-Hoe SM, Hussain N, Cusson RM, Walsh S, Vazquez V, Briere CE, Vittner D. Parental oxytocin responses during skin-to-skin contact in pre-term infants. Early Hum Dev. 2015 Jul;91(7):401-6. doi: 10.1016/j.earlhumdev.2015.04.012. Epub 2015 May 16.

Reference Type BACKGROUND
PMID: 25988992 (View on PubMed)

Cooijmans KHM, Beijers R, Rovers AC, de Weerth C. Effectiveness of skin-to-skin contact versus care-as-usual in mothers and their full-term infants: study protocol for a parallel-group randomized controlled trial. BMC Pediatr. 2017 Jul 6;17(1):154. doi: 10.1186/s12887-017-0906-9.

Reference Type BACKGROUND
PMID: 28683833 (View on PubMed)

Edwards HM. Aetiology and treatment of severe postpartum haemorrhage. Dan Med J. 2018 Mar;65(3):B5444.

Reference Type BACKGROUND
PMID: 29510809 (View on PubMed)

Essa R.M., İsmail N. & İsmail A. (2015). Effect of Early Maternal/Newborn Skin-To- Skin Contact After Birth On The Duration Of Third Stage Of Labor And İnitiation Of Breastfeeding. Journal of Nursing Education and Practice, 54, 98-107.

Reference Type BACKGROUND

Hughes KN, Rodriguez-Carter J, Hill J, Miller D, Gomez C. Using Skin-to-Skin Contact to Increase Exclusive Breastfeeding at a Military Medical Center. Nurs Womens Health. 2015 Dec-2016 Jan;19(6):478-89. doi: 10.1111/1751-486X.12244.

Reference Type BACKGROUND
PMID: 26682656 (View on PubMed)

Karimi, A., Tara, F., Khadivzadeh, T. & Aghamohammadian, Sharbaf, H.R. (2013). The Effect of Skin to Skin Contact Immediately after Delivery on the Maternal Attachment and Anxiety Regarding Infant. Iran J Obstet Gynecol Infertil, 16, 7-15.

Reference Type BACKGROUND

Karimi, F.Z., Bagheri, S., Tara, F., Khadivzadeh, T. & Mousavi, Bazaz, S.M. (2014). Effect ofKangaroo Mother Care on breastfeeding self efficacy in primiparous women, 3 month after child birth. Iran J Obstet Gynecol Infertil, 17, 1-8.

Reference Type BACKGROUND

Linares AM, Wambach K, Rayens MK, Wiggins A, Coleman E, Dignan MB. Modeling the Influence of Early Skin-to-Skin Contact on Exclusive Breastfeeding in a Sample of Hispanic Immigrant Women. J Immigr Minor Health. 2017 Oct;19(5):1027-1034. doi: 10.1007/s10903-016-0380-8.

Reference Type BACKGROUND
PMID: 26969615 (View on PubMed)

Other Identifiers

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2018/066

Identifier Type: -

Identifier Source: org_study_id