Effects of Parenteral Normal Saline and 5% Dextrose in Saline on the Course of Labor. A Randomized, Triple-Blind Controlled Clinical Trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202501662117180

Enrollment

208

Registered

2025-01-16

Start date

2024-12-25

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

Dextrose 5 percent in normal saline D5NS

Normal saline 0.9 percent NaCl

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Nulliparous women in the active phase of spontaneous labor (cervical dilatation 3-5 cm), Gestational age of 36 weeks or longer, Cephalic presentation, Singleton gestation, and Intact or ruptured membranes.

Exclusion criteria

Exclusion criteria: Known diabetes mellitus, Known hypertension, Pre-eclampsia, Cardiac or renal disease, Evidence of chorioamnionitis or fetal distress, Pyrexia, Intrauterine fetal mortality, Scheduled cesarean section, and Epidural analgesia.

Design outcomes

Primary

Measure	Time frame
Primary Outcome Variable is the Total Duration of Labor: The total duration of labor includes both the first and second stages of labor: Stage 1: Active Phase of Labor •Start Time: The clock for labor begins at the onset of active labor (3-5 cm cervical dilation). •End Time: The first stage of labor ends at full cervical dilation (10 cm). Stage 2: Delivery of the Baby •Start Time: Once the cervix is fully dilated (10 cm), the second stage of labor begins. •End Time: The second stage ends with the delivery of the baby.	—

Measure

Time frame

Primary Outcome Variable is the Total Duration of Labor: The total duration of labor includes both the first and second stages of labor: Stage 1: Active Phase of Labor •Start Time: The clock for labor begins at the onset of active labor (3-5 cm cervical dilation). •End Time: The first stage of labor ends at full cervical dilation (10 cm). Stage 2: Delivery of the Baby •Start Time: Once the cervix is fully dilated (10 cm), the second stage of labor begins. •End Time: The second stage ends with the delivery of the baby.

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Secondary

Measure	Time frame
• Secondary Outcomes Variables: • Method of Delivery: Categorical outcome includes vaginal delivery, assisted vaginal delivery, and cesarean section. • Use of Oxytocin: Categorical outcome, where oxytocin is either administered or not (yes/no). • Maternal and neonatal hyponatremia: whether hyponatremia occurred (yes/no). Blood samples will be collected from the mothers on admission and as soon as possible following delivery (results will be coded according to her IVF block). Clamped cord blood samples from the umbilical artery and vein will be collected (will be coded according to the mother IVF block). Samples will be sent to the laboratory to record the sodium level for the coded samples.	—

Measure

Time frame

• Secondary Outcomes Variables: • Method of Delivery: Categorical outcome includes vaginal delivery, assisted vaginal delivery, and cesarean section. • Use of Oxytocin: Categorical outcome, where oxytocin is either administered or not (yes/no). • Maternal and neonatal hyponatremia: whether hyponatremia occurred (yes/no). Blood samples will be collected from the mothers on admission and as soon as possible following delivery (results will be coded according to her IVF block). Clamped cord blood samples from the umbilical artery and vein will be collected (will be coded according to the mother IVF block). Samples will be sent to the laboratory to record the sodium level for the coded samples.

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Countries

Sudan

Contacts

Public ContactDr. Tahani Elfaki Abass Mohieldin

Department of Pharmacology Faculty of Pharmacy University of Gezira

tahanielfaki308@gmail.com00249916358811

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026