P15.5 O70.0 O70.1 O70.2 O70.3 O71.9 O81 O82 P22.9 P21.9 P12.9
Conditions
Interventions
Group 1: Lubricant 1
Sodium chloride
Group 2: Lubricant 2
Hydroxycellulosegel
Group 3: Controlgroup without lubricant
Sponsors
Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum (CVK) & Campus Mitte (CCM) Klinik für Geburtsmedizin
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: - Nullipara - 18 - 45 years old - vital singleton pregnancy - Gestational age >37+0 weeks - vaginal birth from skull-position - fetal estimated weight 2000g - 5000g - at least twice lubricant application (20ml) - max. 50ml lubricant per birth
Exclusion criteria
Exclusion criteria: - Age under 18 years - Persons who are not able to give their consent - Multiple pregnancy - gestational age 5000g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intermittent application of different vaginal lubricants from a cervical dilatation =4cm until birth. Direct application of the lubricant into the birth canal during vaginal examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Obstetric outcome (shortening of second stage of labor and/or total birth time, birth-associated injury of the cervix/vagina/labia/perineum, change to operative vaginal delivery/ secondary caesarean section). 2. Neonatal outcome parameters (apgar score, pH, lactate acidosis, stress marker copeptin, birth trauma, transfer to the children's clinic) | — |
Countries
Germany
Contacts
Public ContactTEAM GLIDE
Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
Outcome results
None listed