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Keep this study
Lead
Ferring Pharmaceuticals
PK study in women requiring cervical ripening.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Pregnant women at ≥36 weeks 0 days inclusive gestation;
Aged 18 years or older;
Candidate for pharmacologic induction of labor;
Singleton pregnancy;
Baseline modified Bishop score \<4 (see Appendix B);
Nulliparous (nulliparous is defined as no previous births live or dead after 24 weeks gestation);
Written informed consent.
You may not be if
Women with hemoglobin level \< 11.0 g/dL (confirmed within one week of study drug insertion);
Women in active labor;
Presence of uterine or cervical scar or uterine abnormality e.g. bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or pregnancy inducted hypertension;
Severe pre-eclampsia marked by CNS findings, HELLP syndrome, or other end-organ affliction;
Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation;
Diagnosed fetal abnormalities;
Suspected or confirmed intrauterine growth retardation (less than 10% estimated fetal weight for dates);
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
Receipt of NSAID (including aspirin) within 4 hours of study treatment;
Ruptured membranes ≥48 hours prior to the start of treatment or suspected chorioamnionitis;
Fever (oral or aural temperature \> 37.5C);
Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.
Clareo Health | Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
