Labor, First Stage, Labor, Second Stage
Conditions
Brief summary
Perineal massage at the end of labor stage 2 has been investigated in 2 randomized controlled trials using a water soluble lubricant. In one trial a significant reduction of labor stage 2 has been found, both trials did not show a significant increase of perineum integrity. In the HCB Swiss Study both a significant reduction of labor stage 2 by 30 % as well as a significant increase of perineal integrity have been shown. No adverse events have been reported. (see also Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. J Perinat Med 2008; 36 (2): 129-135). Today's practice- Lubricants are widely used to enable manual vaginal examination during labor. In Israel midwifes are using Almond Oil for perineal massage at the end of labor stage 2 to protect the perineum. It has been shown for the first time that the use of the Dianatal Obstetric Gel facilitates vaginal childbirth in humans. Dianatal has been introduced to the EU markets in 2008.
Interventions
DEVICEDianatal Obstetric Gel (Cross-linked polyacrylic acid)
Dianatal (approx. 30 mL in total) will be intermittently administered to the birth canal after vaginal examination in labor using the Dianatal applicator or the syringe or the fingers. Dianatal Stage I is used during labor stage I, Dianatal Stage 2 is used during stage 2. After rupture of the membranes supplementary Dianatal is applied within 5 to 20 minutes.
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Maternal age between 18 and 40 years * signed written informed consent, * intention for vaginal delivery, * nulliparous state or multiparous state * singleton baby in vertex presentation * estimated birth weight between 1500 g and 4500 g * low risk pregnancies at term and late preterm (34 to 42weeks of gestational age)
Exclusion criteria
* contraindications for vaginal delivery * indications for an amnion infection syndrome * suspect for fetal malformations * indications for cephalopelvic disproportion * severe concomitant diseases of the mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects on c-section rates | — |
| Effects on vaginal operative intervention rates (forceps, vaccum) | — |
| Effects on prolonged second stage | — |
| Effects on vaginal and Perineum: tears | — |
| Effect on episiotomy rate | — |
| Effect on labor outcome in premature infants | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on postpartum vaginal or urethral burn feeling | — |
| Effect on newborn outcomes (APGAR score 1, 5 and 10 min after birth; umbilical cord pH; reduction of newborn trauma) | — |
| Effect on labor duration stage 2 (full dilatation of the cervix until delivery of the baby). | — |
| Effect on labor duration stage 1 (cervical dilatation of uterus between 4 cm and 10 cm, the beginning of stage 1, i.e. 4 cm dilatation should be evaluated as close as possible within routine examination periods) | — |
| Effect on birth trauma (birth canal lacerations): vaginal lesions, perineal lesions | — |
| Effect on labor outcomes in state after c-section | — |
| Effect on pain experience (pain reduction) measured by visual analog scale: use of epidural | — |
Countries
Israel
Contacts
Primary ContactBoris Kaplan, MD, Prof.
Backup ContactYarin Yogev, MD
Outcome results
None listed