Clinical trial NCT04425096: The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding
Official title: The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin to Skin Contact
Keywords: Postpartum Pain
Breastfeeding
Beta Endorphin
Oxytocin
Postpartum Hemorrhage
Skin to Skin Contact
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled single-blind experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxytocin Analysis
timeFrame: 1 minute -30 minutes.
measure: ᵦ endorphin Analysis
timeFrame: 1 minute -30 minutes.
measure: VAS (Visuel Analog Scale)
timeFrame: 2nd hour- 6 th hour
measure: LATCH Breastfeeding Assessment Tool
timeFrame: 24th hour -1st week
measure: Breastfeeding Self-Efficacy Scale
timeFrame: 24th hour -1st week
measure: Postpartum Blood Bag
timeFrame: 24th hour
measure: Total Postpartum Blood Loss
timeFrame: 24th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglık Bilimleri Universitesi
Study officials:
affiliation: Saglık Bilimleri U
name: Yasemin AYDIN KARTAL, PhD
role: STUDY_DIRECTOR
References:
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citation: Annagür, B. & Annagür, A. (2012). Relationship of Postpartum Mental Status with Breastfeeding. Current Approaches in Psychiatry, 4, 279-292
citation: 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
citation: 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.
citation: 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.
citation: Edwards HM. Aetiology and treatment of severe postpartum haemorrhage. Dan Med J. 2018 Mar;65(3):B5444.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.