Induced Vaginal Delivery
Conditions
Keywords
labor induction, papaverine, propess, bishop score, induction to delivery interval
Brief summary
The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval. Researchers will compare drug papaverine to a placebo
Detailed description
More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (\<6), are prone to higher induction failure rates and are candidates for cervical ripening. The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval
Interventions
DRUGPapaverine
Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline
OTHERplacebo
I.V Sallne
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who inserted the PGE2 (propess), the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* singleton term pregnancy * bishop score * need for labor induction with PGE2 * vertex presentation * viable fetus
Exclusion criteria
* Prelabour rupture of membrane * Twins pregnancy * previous cesarean section * allergy to the study medication * fetal anomaly contraindications for vaginal delivery * maternal supraventricular tachicardia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta Bishop score | 24 hours | The bishop score before and after propess insertion |
| the time from propess insertion until delivery | 72 hours | induction to delivery time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale score | 24 hours | pain assessment using a 10-point visual analogue scale |
| maternal satisfaction scores | 24 hours | maternal satisfaction on 1-5 scale. higher scores mean higher satisfaction |
Countries
Israel
Outcome results
None listed