Labor, Pregnancy, Second Stage of Labor
Conditions
Keywords
Second stage of labor, Oral carbohydrate intake, Non-pharmacologic intervention, Maternal exhaustion, Pregnancy, Labor, Randomized controlled trial
Brief summary
Childbirth is an energy-intensive physiological process, requiring sustained effort comparable in intensity to moderate physical activity. Studies suggest that providing an available energy source during labor, such as dextrose infusion or natural carbohydrate-rich foods such as dates, may shorten the duration of labor and improve cervical dilation without adversely affecting obstetric outcomes. The primary objective of the study is to examine whether giving chocolate during labor affects the duration of the second stage of labor, compared to a control group that will not receive a nutritional intervention. The study is a prospective, randomized, controlled trial that will be conducted in the delivery room of Hillel Yaffe Medical Center. Healthy pregnant women with a singleton pregnancy at ≥37 weeks gestational age, in spontaneous or induced labor, without diabetes (pre/gestational), will be recruited to participate. Participants in the intervention group will receive one serving of 50 grams of milk chocolate (cocoa content 25-30%, without filling or additives) at a cervical dilation of 6 cm or more (and not yet fully dilated). The mother will be asked to consume the serving gradually over 30 minutes. Milk chocolate was chosen because it is better tolerated compared to dark chocolate, has a more gentle profile of active ingredients (which can increase nausea and heartburn) and provides a source of available carbohydrates. The study will be conducted in accordance with the guidelines of the Ministry of Health's procedure for medical experiments on humans, and will be conducted after approval by the Institutional Helsinki Committee.
Interventions
OTHER50 g of milk chocolate cocoa content 25-30%
Milk chocolate was chosen as it is better tolerated compared to dark chocolate, has a milder profile of active ingredients (which can increase nausea and heartburn) and provides a source of available carbohydrates. A dose of 50 grams was chosen that provides 25-30 grams of simple carbohydrates - sufficient for a significant increase in blood glucose but low enough to prevent a sudden sugar load or nausea. The intervention will be given at 6-9 cm dilation, towards the transition to the second phase - to allow the absorption of glucose and neurochemicals to be deafened at a time when the body needs increased energy and alertness. Giving it earlier may result in the effect of the chocolate wearing off before the second phase, and later - there will be no time for effective absorption.
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study. Masking is not feasible due to the nature of the intervention. However, the primary outcome is an objective measure, minimizing the risk of assessment bias.
Intervention model description
This is a randomized, parallel-group interventional study. Eligible participants will be randomized in a 1:1 ratio to receive either oral carbohydrate supplementation (chocolate) prior to second stage of labor, or standard intrapartum care. Outcomes will be compared between groups. The primary outcome is the duration of second stage of labor, with secondary maternal and neonatal outcomes assessed.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Gestational age ≥37 weeks 2. Single fetus in cephalic presentation 3. Spontaneous or induced labor in the active phase (dilation ≥ 5 cm). 4. Normal assessment of the mother and fetus upon admission to the delivery room (normal indices, normal monitoring and biophysical profile) 5. BMI 18-35 -
Exclusion criteria
1. Multiple pregnancies 2. Gestational age \<37 weeks 3. Gestational or pre-gestational diabetes 4. Significant underlying diseases 5. Previous cesarean section/myomectomy 6. Known significant fetal malformation 7. Sensitivity to chocolate ingredients 8. Lack of documentation of necessary information -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of second stage of labor | From full cervical dilation to delivery | The duration of the second stage of labor, defined as the time in minutes from full cervical dulation (10cm) to delivery of the neonate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | At delivery | Mode of delivery categorized as spontanous vaginal delivery, operative vaginal delivery (vacuum), or cesarean delivery |
| Maternal nausea or vomiting during labor | From intervention administration untill discharge from labor room | The occurrence of maternal nausea or vomiting during labor following the assigned intervention, as documented in the medical record |
| Neonatal Apgar score at 1 and 5 minutes | 1 and 5 minutes after delivery | The Apgar score is assessed at 1 and 5 minutes after delivery. The total score ranges from 0 to 10, with higher scores indicating better neonatal condition. |
| Umbilical cord blood glucose level | at delivery | Umbilical cord blood glucose concentration measured from umbelical blood collected immediately after delivery (when a cord blood sample is obtained per routine practice |
| Maternal heart rate | During the second stage of labor | Maternal heart rate measured in beats per minute as recorded by continous intrapartum maternal monitorind |
| Umbelical cord blood PH | At delivery | Umbelical cord blood PH measures immediatley after delivery |
Contacts
CONTACTLibby O Madar, M.D
CONTACTRinat Gabbay-Benziv, M.D
Outcome results
None listed