Dinoprostone cervical gel.
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Administration, Intravaginal↗
Biomedical subjects
M L Noah
Publications and source records attributed to M L Noah.
Preinduction cervical softening with endocervical PGE2 gel. A multi-center trial.
In a prospective, randomized trial, a single dose of PGE2 gel, 0.5 mg (2.5 ml), was given to 416 low Bishop Score patients 12 h prior to indicated oxytocin induction and compared with 404 non-gel controls. Successful initial induction was achieved in 83% of the treated and 58% of the non-treated subjects. In addition the induction-delivery interval was shortened (median times 9.0 h vs. 11.3 h) and fewer cesarean sections were performed (16% vs. 21%) in the PGE2 gel series. The endocervical administration of PGE2 was well tolerated and, provided care is taken to avoid excess extra-amniotic placement, systemic PGE2 effects are minimal.
Adult↗
The effect of endocervical PGE2-gel (Prepidil) gel on plasma levels of 13,14-dihydro-15-keto-PGE2 (PGEM) in women at term.
Term pregnant patients undergoing preinduction cervical softening were randomized to receive no treatment (controls) or 0.5 mg PGE2-triacetin gel (Prepidil gel) endocervically. Plasma samples containing PGEM collected 4 hrs post-treatment and converted to the stable bicyclo degradation product (bicyclo-PGEM) were assayed by RIA. Positive clinical effect (responders) during 12 hrs after treatment (Bishop score increase greater than or equal to 3, in labor or delivered) were assessed. All evaluations were blind. In nonresponders (n = 35), the means of the bicyclo-PGEM variables (mean, maximum, area under the curve) were all about 18% higher in gel-treated patients (n = 6) than controls (n.s.). In responders (n = 38), the variables were all about 80% higher in gel-treated women (n = 32) than controls (p less than .01). In controls (n = 35), the responders (n = 6) had 50% higher levels than nonresponders (n.s.). In the gel-treated women (n V 38), responders (n = 32) had about 140% higher levels than nonresponders (less than .01). The results suggest that both exogenous and endogenous bicyclo-PGEM were measured. Differences in pairwise comparisons suggest that there may be substantially less exogenous bicyclo-PGEM in the gel nonresponders than in gel responders or substantially more endogenous bicyclo-PGEM in gel responders than in control-responders.
Adolescent↗
Assessment of a two dose scheme of PGE2 gel for preinduction cervical softening.
A single dose technique of endocervically administered 0.5 mg PGE2 triacetin gel has been reliably effective for preinduction cervical softening. This study examined the value of a 2 times 0.25 mg dosing scheme over a 12 hour period and compared it with the single dose method. It was concluded that there was no advantage in the two dose scheme and given the potential for contamination or inadvertent rupture of the membranes with more frequent dosing, the single application remains the procedure of choice.
Adult↗
Endocervical prostaglandin E2 gel for preinduction cervical softening.
A single, endocervical application of a new commercial preparation of prostaglandin E2 (PGE2) gel, 0.5 mg of PGE2 in 2.5 ml (3 g), was evaluated for preinduction cervical softening. Safety and efficacy were assessed in a comparison with a 2.0 mg PGE2 vaginal tablet and placebo in normal nulliparous women at term, with low Bishop scores. Treatment was administered in randomized, double blind fashion. Overall success, defined as a progression in Bishop score of at least 3 points within 12 hours, was achieved in 22/40 (55%) of the gel group, 15/41 (37%) in the tablet treated women, and 8/40 (20%) in those receiving placebo. Of interest was the observation that of women with very unfavorable induction features (Bishop score 0-2), the cervical gel treatment resulted in a 6/8 (75%) success rate compared with 2/13 (15%) success for the vaginal tablet and 0/17 (0%) for placebo. In as much as a very low incidence of side effects accompanied this treatment scheme, expanded multi-center testing is recommended.
Adult↗
Management of severe postpartum hemorrhage with a prostaglandin F2 alpha analogue.
Presented is a three-year study using a 15-methyl analogue of prostaglandin F2 alpha, in the management of severe postpartum hemorrhage due to uterine atony in patients who were unresponsive to conventional therapies. Fifty-four patients were entered into the study, but 51 were analyzed for efficacy. Successful control of postpartum hemorrhage occurred in 86%. Of the seven in whom therapy failed and who subsequently required surgical therapy, four had chorioamnionitis. Six subjects had intramyometrial injection of the agent, with dramatic results in five. Mild transient side effects occurred in less than 10% of subjects.
Adult↗
Gastrointestinal propulsion measurement with radiopaque capsules during 16,16-dimethyl PGE2 infusion.
A method to quantitate gastric emptying (GE) and small intestinal transit (SIT) by obtaining serial abdominal x-rays after administration of radiopaque capsules was developed. The technique was verified by studying gastric emptying and small intestinal transit in healthy volunteers treated with subcutaneous injections of 0.4 or 0.8 mgs of atropine, 2.5 mg bethanechol, or saline placebo. Atropine decreased gastric emptying and small intestinal transit, and bethanechol only increased gastric emptying. The suitability of this technique for measuring gastrointestinal propulsion in post-operative patients was demonstrated in females undergoing hysterectomy. The small intestine recovered propulsive ability at least six hours sooner than the stomach. This technique was also used while performing a single dose, intravenous tolerance study of 16,16-dimethyl prostaglandin E2 (DmPGE2) in normal volunteers. DmPGE2 was administered over five minutes at a dose of 7 to 140 ng/kg. DmPGE2 was well tolerated producing only minor side effects that were not dose related. In doses up to 70 ng/kg, DmPGE2 increased gastric emptying and inhibited small intestinal transit. The delayed small intestinal transit may make DmPGE2 an inappropriate choice for treatment of post-operative or paralytic ileus.
Adolescent↗
Management of severe postpartum hemorrhage due to uterine atony using an analogue of prostaglandin F2 alpha.
Twenty patients with severe postpartum hemorrhage due to uterine atony who were unresponsive to conventional therapy were treated with 0.25-mg intramuscular injections of (15-S)-15-methyl prostaglandin F2 alpha-tromethamine. A rapid and successful response was obtained in 18 patients. Two patients required surgical procedures to control bleeding. Both patients with treatment failure had chorioamnionitis. Side effects of the prostaglandin therapy included nausea, vomiting and diarrhea, a transient mild temperature elevation, and a transient moderate blood pressure elevation. Those subjects with preeclampsia did not demonstrate a serious elevation of blood pressure. The prostaglandin F2 alpha analogue appears to be very effective in the treatment of postpartum hemorrhage due to uterine atony.
Adult↗
Use of prostaglandin E1 for maintaining the patency of the ductus arteriosus.
Prostaglandin E1 was utilized for maintaining the patency of the ductus arteriosus in 19 infants with congenital lesions whose survival depended on ist patency. Fourteen of the patients had lesions which required blood flow from the aorta to the pulmonary artery (cyanotic group); 11 of these were considered successful. Two of the failures were in older infants aged 13 days and 1 month. The remaining five trials were in patients who required a flow of blood from pulmonary artery to aorta (left heart and aortic defect group), two of whom were considered to have responded successfully to the prostaglandin E1 administration. Based on this experience, it is suggested that this method of treatment is of benefit in the cyanotic group in providing emergency medical care while awaiting surgical palliation. A similar benefit in the aortic arch defect group would seem to be less well demonstrated at this time.
Clinical Trials as Topic↗