Biomaterial Database

[Efficacy and safety of mifepristone combined with misoprostol for termination of pregnancy between 8 and 16 weeks of gestation]. 2015

Jinfeng Qian, and Xiaoping Jing, and Shuying Wu, and Shurong Zheng, and Yi Li, and Mulan Ren, and Wen Di, and Huan Shen, and Baihua Dong, and Qing Chang, and Huirong Shi, and Chen Yao, and Wei Song, and Zirong Huang

Department of Family Planning, Obstetrics and Gynecology Hospital, Fudan University, Shanghai 200011, China.

OBJECTIVE To assess the efficacy and safety of mifepristone combined with oral or vaginal misoprostol for termination of pregnancy between 8 and 16 weeks of gestation. METHODS This was a randomized, multi-center, open clinical trial. A total of 625 women at 8-16 weeks of gestation were randomized to receive 200 mg oral mifepristone followed by either oral misoprostol 400 µg every 3 hours or vaginal misoprostol 400 µg every 6 hours for a maximum of 4 doses 36-48 hours later. There were 417 women in oral group with 198 at 8-9 weeks and 219 at 10-16 weeks, while 208 women in vaginal group with 99 at 8-9 weeks and 109 at 10-16 weeks. The outcome measures were the success abortion rate, induction to abortion interval, the amount of bleeding, reoccurrence of menstruation and adverse events. RESULTS Abortion rate was significantly higher in vaginal group [98.1% (202/206)] than that in oral group [94.0% (390/415), P = 0.023]; concerning termination of pregnancy at 8-9 weeks and 10-16 weeks respectively, there were no significant differences between oral and vaginal groups (P = 0.156, P = 0.073). The induction to abortion interval was no significant difference in oral and vaginal group in different gestational weeks (P = 0.238, P = 0.273). The average induction to abortion interval was (4.1 ± 6.6) hours and (6.0 ± 4.5) hours respectively in terminating 8-9 weeks and 10-16 weeks of gestation. Concerning the amount of bleeding within 2 hours of placenta expulsion, there was significant difference between oral group [(63 ± 46) ml] and vaginal group [(55 ± 45) ml] in terminating 8-9 weeks of gestation (P = 0.047), while there was no significant difference between groups in terminating 10-16 weeks of gestation [oral group (76 ± 52) ml versus vaginal group (76 ± 61) ml, P = 0.507]. The reoccurrence of menstruation was about 37 days in both oral and vaginal groups. Two cases of incomplete abortion were serious adverse events (SAE) relating to treatment. The common adverse events (AE) of nausea and vomiting were significantly higher in oral group [57.2% (239/417), 36.3% (151/417)] than those in vaginal group [45.4% (94/208), 26.1% (54/208); P = 0.005, 0.011]. CONCLUSIONS Oral or vaginal misoprostol combined with mifepristone, is effective and safe for termination of pregnancy between 8 and 16 weeks of gestation.

UI	MeSH Term	Description	Entries
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
D011261	Pregnancy Trimester, First	The beginning third of a human PREGNANCY, from the first day of the last normal menstrual period (MENSTRUATION) through the completion of 14 weeks (98 days) of gestation.	Early Placental Phase,Pregnancy, First Trimester,Trimester, First,Early Placental Phases,First Pregnancy Trimester,First Pregnancy Trimesters,First Trimester,First Trimester Pregnancies,First Trimester Pregnancy,First Trimesters,Phase, Early Placental,Phases, Early Placental,Placental Phase, Early,Placental Phases, Early,Pregnancies, First Trimester,Pregnancy Trimesters, First,Trimesters, First
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
D005260	Female		Females
D005865	Gestational Age	The age of the conceptus, beginning from the time of FERTILIZATION. In clinical obstetrics, the gestational age is often estimated from the onset of the last MENSTRUATION which is about 2 weeks before OVULATION and fertilization. It is also estimated to begin from fertilization, estrus, coitus, or artificial insemination.	Embryologic Age,Fetal Maturity, Chronologic,Chronologic Fetal Maturity,Fetal Age,Maturity, Chronologic Fetal,Age, Embryologic,Age, Fetal,Age, Gestational,Ages, Embryologic,Ages, Fetal,Ages, Gestational,Embryologic Ages,Fetal Ages,Gestational Ages
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000020	Abortifacient Agents, Nonsteroidal	Non-steroidal chemical compounds with abortifacient activity.	Abortifacient Agents, Non-Steroidal,Abortifacient Agents, Non Steroidal,Agents, Non-Steroidal Abortifacient,Agents, Nonsteroidal Abortifacient,Non-Steroidal Abortifacient Agents,Nonsteroidal Abortifacient Agents
D000028	Abortion, Induced	Intentional removal of a fetus from the uterus by any of a number of techniques. (POPLINE, 1978)	Embryotomy,Abortion (Induced),Abortion Failure,Abortion History,Abortion Rate,Abortion Technics,Abortion Techniques,Abortion, Drug-Induced,Abortion, Rivanol,Abortion, Saline-Solution,Abortion, Soap-Solution,Anti-Abortion Groups,Fertility Control, Postconception,Induced Abortion,Previous Abortion,Abortion Failures,Abortion Histories,Abortion Rates,Abortion Technic,Abortion Technique,Abortion, Drug Induced,Abortion, Previous,Abortion, Saline Solution,Abortion, Soap Solution,Abortions (Induced),Abortions, Drug-Induced,Abortions, Induced,Abortions, Previous,Abortions, Rivanol,Abortions, Saline-Solution,Abortions, Soap-Solution,Anti Abortion Groups,Anti-Abortion Group,Drug-Induced Abortion,Drug-Induced Abortions,Embryotomies,Failure, Abortion,Failures, Abortion,Group, Anti-Abortion,Groups, Anti-Abortion,Histories, Abortion,History, Abortion,Induced Abortions,Postconception Fertility Control,Previous Abortions,Rate, Abortion,Rates, Abortion,Rivanol Abortion,Rivanol Abortions,Saline-Solution Abortion,Saline-Solution Abortions,Soap-Solution Abortion,Soap-Solution Abortions,Technic, Abortion,Technics, Abortion,Technique, Abortion,Techniques, Abortion
D000282	Administration, Intravaginal	The insertion of drugs into the vagina to treat local infections, neoplasms, or to induce labor. The dosage forms may include medicated pessaries, irrigation fluids, and suppositories.	Administration, Vaginal,Drug Administration, Vaginal,Instillation, Vaginal,Intravaginal Administration,Vaginal Drug Administration,Vaginal Administration,Administration, Vaginal Drug,Administrations, Intravaginal,Administrations, Vaginal,Administrations, Vaginal Drug,Drug Administrations, Vaginal,Instillations, Vaginal,Intravaginal Administrations,Vaginal Administrations,Vaginal Drug Administrations,Vaginal Instillation,Vaginal Instillations
D000284	Administration, Oral	The giving of drugs, chemicals, or other substances by mouth.	Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations