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临床试验/NCT07535684
NCT07535684
已完成
不适用

Impact of Early Essential Newborn Care (EENC) on Maternal and Neonatal Outcomes in a Tertiary Care Hospital

Sheikh Zayed Medical College1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2025年5月5日最近更新:

概览

阶段
不适用
状态
已完成
入组人数
162
试验地点
1
主要终点
Successful First Breastfeeding

概览

简要总结

This study was examine whether Early Essential Newborn Care (EENC), a simple package of care given immediately after birth, could improve the health of both mothers and newborns compared with the routine care currently provided in the hospital. EENC included drying the baby right after birth, placing the baby in direct skin-to-skin contact with the mother, delaying cord clamping until pulsations stop, keeping the baby warm, and helping breastfeeding start within the first hour. In the routine care group, babies were received the usual hospital care, which may include early cord clamping, placement under a radiant warmer, and later skin-to-skin contact and breastfeeding.

A total of 162 mother-baby pairs were enrolled at Shaikh Zayed Hospital, Rahim Yar Khan, and randomly assigned to either the EENC group or the routine care group. The study was included women aged 18 to 40 years with singleton term pregnancies who deliver vaginally, and whose babies are expected to weigh at least 2500 grams. Mothers with serious medical or obstetric problems, and newborns with major abnormalities or medical conditions, were not included.

The study was compared important newborn outcomes such as early breastfeeding, time to first breastfeeding, exclusive breastfeeding up to 7 days, low body temperature, low blood sugar in at-risk babies, admission to the neonatal intensive care unit, eye infection, and confirmed infection during the first week of life. Maternal outcomes such as the duration of the third stage of labor, blood loss after delivery, pain, and anxiety were also measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female age ≥ 18 to 40 years.
  • Gestational age between 37 and 41+6 weeks at the time of delivery.
  • Singleton pregnancies confirmed by antenatal assessment.
  • Estimated fetal birth weight of 2500 grams or more, based on obstetric ultrasonography.
  • Mothers intending to remain admitted in the hospital for a minimum of 24 hours following delivery.
  • Delivery must be completed via the vaginal route.

排除标准

  • Women who undergo emergency cesarean section.
  • Neonates presenting with congenital deformities.
  • Newborns with structural anomalies or medical conditions.
  • Mothers experiencing severe obstetric complications or having significant underlying medical illnesses.
  • Mothers with contraindications to breastfeeding due to medical conditions (e.g., HIV infection, syphilis, prior breast surgeries, mastitis, or breast abscess).
  • Women who decline or are unable to provide informed consent.
  • Mother-infant dyads transferred to another healthcare facility within 24 hours postpartum.

研究组 & 干预措施

Early Essential Newborn Care Group

Experimental

Received Early Essential Newborn Care immediately after vaginal birth, including immediate drying, uninterrupted skin-to-skin contact, delayed cord clamping, thermal protection, and breastfeeding initiation within the first hour.

干预措施: Early Essential Newborn Care (Procedure)

Routine Postnatal Care Group

Active Comparator

Received standard hospital postnatal care, including immediate drying, radiant warmer care, prompt cord clamping, routine newborn care, and later skin-to-skin contact and breastfeeding according to usual practice.

干预措施: Routine Postnatal Care (Procedure)

结局指标

主要结局

Successful First Breastfeeding

时间窗: assessed within 24 hours postpartum

Proportion of newborns with successful first breastfeeding, defined as an Infant Breastfeeding Assessment Tool score of 10 or more out of 12 during the first breastfeeding session after birth.

次要结局

  • Early Breastfeeding Initiation(Within the first 60 minutes after birth)
  • Exclusive Breastfeeding Rate at Day 7(From birth to day 7 postpartum)
  • Incidence of Neonatal Hypothermia(Within the first 24 hours after birth)
  • Admission to Neonatal Intensive Care Unit(Within the first 24 hours after birth)
  • Neonatal Infection(Within the first 7 days of life)
  • Postpartum Blood Loss(Within the first 24 hours postpartum)
  • Maternal Anxiety Score(120 minutes after delivery)
  • Maternal Pain Score at 30 Minutes(30 minutes after delivery)
  • Maternal Pain Score at 2 Hours(2 hours after delivery)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kainat usman

Principal Investigator

Sheikh Zayed Medical College

研究点 (1)

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