Biomaterial Database

Lamicel versus laminaria for cervical dilation before early second-trimester abortion: a randomized clinical trial. 1987

D A Grimes, and I G Ray, and C J Middleton

Lamicel is a synthetic osmotic cervical dilator reported to work within two hours. To evaluate its efficacy and side effects, we conducted a double-blind, randomized clinical trial comparing Lamicel with multiple laminaria for cervical dilation in 219 patients before second-trimester abortion. A single Lamicel produced significantly less initial dilation (two-tailed P value = .03) than did multiple laminaria, but the techniques had comparable degrees of difficulty in subsequent dilation to 43 French units (two-tailed P value greater than .05) and rates of achieving dilation of 43 French units with rigid dilators (relative risk 1.0; 95% confidence interval 0.9-1.1). Lamicel removal resulted in a significantly lower rate of bleeding from the os (relative risk 0.3; 95% confidence interval 0.2-0.5). Because of its greater convenience, lower cost per patient, and comparable efficacy, Lamicel appears to be an attractive alternative to multiple laminaria for cervical dilation before abortion at 14-16 menstrual weeks' gestation.

UI	MeSH Term	Description	Entries
D007795	Laminaria	A genus of BROWN ALGAE in the family Laminariaceae. Dried pencil-like pieces may be inserted in the cervix where they swell as they absorb moisture, serving as osmotic dilators.	Kjellmaniella,Laminaria Tents,Saccharina,Laminaria Tent
D008278	Magnesium Sulfate	A small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. (From AMA Drug Evaluations Annual, 1992, p1083)	Magnesium Sulfate, Heptahydrate,Heptahydrate Magnesium Sulfate,Sulfate, Magnesium
D011142	Polyvinyl Alcohol	A polymer prepared from polyvinyl acetates by replacement of the acetate groups with hydroxyl groups. It is used as a pharmaceutic aid and ophthalmic lubricant as well as in the manufacture of surface coatings artificial sponges, cosmetics, and other products.	Liquifilm Tears,Polyviol,Alcohol, Polyvinyl,Tears, Liquifilm
D011247	Pregnancy	The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.	Gestation,Pregnancies
D011262	Pregnancy Trimester, Second	The middle third of a human PREGNANCY, from the beginning of the 15th through the 28th completed week (99 to 196 days) of gestation.	Midtrimester,Pregnancy, Second Trimester,Trimester, Second,Midtrimesters,Pregnancies, Second Trimester,Pregnancy Trimesters, Second,Second Pregnancy Trimester,Second Pregnancy Trimesters,Second Trimester,Second Trimester Pregnancies,Second Trimester Pregnancy,Second Trimesters,Trimesters, Second
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D002584	Cervix Uteri	The neck portion of the UTERUS between the lower isthmus and the VAGINA forming the cervical canal.	Cervical Canal of the Uterus,Cervical Canal, Uterine,Ectocervix,Endocervical Canal,Endocervix,External Os Cervix,External Os of the Cervix,Uterine Cervical Canal,Cervix,Cervixes,Uterine Cervix,Canal, Endocervical,Canal, Uterine Cervical,Cervix, External Os,Cervix, Uterine,Endocervical Canals,Uterine Cervical Canals
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004106	Dilatation	The act of dilating.	Dilation,Dilatations,Dilations
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked