Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/7/2015 |
| Start Date: | July 2011 |
| End Date: | December 2013 |
| Contact: | Linh Tran, MD |
| Email: | LinhTran@mednet.ucla.edu |
| Phone: | 310 825 6301 |
Buccal Versus Vaginal Misoprostol for the Third Trimester Induction of Labor
Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue,
is a widely accepted induction agent, that has been proven safe and effective for induction
of labor. It stimulates both cervical ripening and uterine contractions, thus making it an
ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics
of different administration routes and effects on uterine contractility, side effects, and
safety. Vaginal misoprostol has been shown to be superior over oral administration however
patients often prefer a more tolerable route. Buccal administration has already been shown
to be as effective as vaginal misoprostol for cervical ripening and induction in both first
trimester and second trimester abortions. There is minimal research comparing buccal versus
vaginal for third trimester induction of labor. The investigators study is a prospective,
double blinded, randomized control trial comparing vaginal misoprostol and buccal
misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question
whether buccal misoprostol is as effective as vaginal misoprostol for third trimester
induction of labor.
is a widely accepted induction agent, that has been proven safe and effective for induction
of labor. It stimulates both cervical ripening and uterine contractions, thus making it an
ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics
of different administration routes and effects on uterine contractility, side effects, and
safety. Vaginal misoprostol has been shown to be superior over oral administration however
patients often prefer a more tolerable route. Buccal administration has already been shown
to be as effective as vaginal misoprostol for cervical ripening and induction in both first
trimester and second trimester abortions. There is minimal research comparing buccal versus
vaginal for third trimester induction of labor. The investigators study is a prospective,
double blinded, randomized control trial comparing vaginal misoprostol and buccal
misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question
whether buccal misoprostol is as effective as vaginal misoprostol for third trimester
induction of labor.
Design Overview This will be a prospective, double blind, randomized, placebo-controlled
trial comparing buccal versus vaginal misoprostol in equal doses (25 mcg every 4 hours).
Each participant will receive one buccal and one vaginal tablet, only one containing
misoprostol. The administration will be repeated every four hours if contractions are
inadequate (frequency less than every 5 minutes) until the cervix is favorable, spontaneous
rupture of membranes occurs, or the patient is in active labor. Patient will be continued on
intermittent fetal heart monitoring 1 hour after administration. Prior to discharge women in
the study will be asked to complete a questionnaire as to their preferences of route of
administration and side effects.
1. Recruitment, Consenting, and Confirming Eligibility: Women with obstetric, medical, or
psychosocial indications of induction of labor at UCLA Ronald Reagan Medical Center
will be evaluated for participation. Those who meet eligibility criteria will be
invited to participate. The subject will be counseled about the study, and if
interested, will undergo the consent process. Each potential subject will receive a
thorough overview of the study protocol and will review the consent form with study
staff. All questions will be answered. The subject will be advised that a decision not
to participate in the study will not affect the quality or availability of medical
services she will receive at the hospital. She will also be advised that she can stop
participating in the study at any time, for any reason, and that this will not impact
the services she receives. If the subject elects to participate, two copies of the
consent will be signed by the subject and research staff. A signed consent, along with
a copy of the Experimental Subjects Bill of Rights, will be given to the subject. The
other consent will be filed in a locked file cabinet.
A general medical and gynecological history and physical will be done as is standard of
care. Routine obstetric labs and any other medically indicated labs will be sent as is
standard of care. Patients will undergo a non-stress test and uterine contraction
monitoring prior to induction of labor. Obstetrical ultrasound will be reviewed or
performed if indicated per the physician. Assessment of the cervix and Bishop score,
pelvis, fetal size, and presentation will be performed. An unfavorable cervix is
defined as Bishop score of 6 or less (ACOG). Women with ruptured membranes will not be
able to participate. Gestational age will be determined on the basis of last menstrual
period, confirmed by earliest ultrasound, or a corrected estimated date of confinement
by the earliest ultrasound.
2. Misoprostol Administration/ Evaluation: The subject will be randomized to either of two
groups. Each participant will receive both a vaginal and buccal tablet, with one tablet
containing misoprostol. Subjects will be instructed by a nurse regarding buccal
placement and to swallow any residue remaining after 20 minutes.
Intravaginal administration of pill will be performed by a resident Physician or
midwife. The subject will remain recumbent for at least 30 minutes. The subject will
undergo fetal heart rate (FHR) and uterine contraction monitoring for at least 1 hour
after misoprostol administration. The subject may undergo further FHR and uterine
contraction monitoring per physician discretion. If the subject does not have adequate
uterine contractions (uterine contraction occurring at least every 5 minutes), the same
dosage and route of administration regimen will be repeated to 6 maximum dosage
(maximum of 150mcg). Cervical assessment of Bishop score will be performed with each
treatment during vaginal administration.
Treatment will continue until spontaneous rupture of membranes, active labor, or
favorable cervix (Bishop >6). Augmentation of labor using pitocin may start after 4
hours of last misoprostol dose according to routine protocol. Amniotomy may be
performed at the discretion of the managing obstetrician. If labor is not achieved
after receiving 150mcg of misoprostol, it will be categorized as a failed induction. At
this time, the subject may be offered oxytocin induction, foley bulb mechanical
dilation, or cesarean section, according to the fetal and participant condition.
Terbutaline 0.25mg subcutaneous may be given for tachysystole (5 uterine contractions
in 10 minutes) with FHR changes or FHR category II-III changes (minimal variability,
prolonged deceleration, repetitive variables, sinusoidal pattern, repetitive late
deceleration) that are not responsive to resuscitative measures ( oxygen
supplementation, side positioning, intravenous fluids) according to physician's
discretion.
3. Follow up: A short survey questionnaire assessing gastrointestinal side effects,
experiences, and preferences of route of administration will be given prior to
discharge.
trial comparing buccal versus vaginal misoprostol in equal doses (25 mcg every 4 hours).
Each participant will receive one buccal and one vaginal tablet, only one containing
misoprostol. The administration will be repeated every four hours if contractions are
inadequate (frequency less than every 5 minutes) until the cervix is favorable, spontaneous
rupture of membranes occurs, or the patient is in active labor. Patient will be continued on
intermittent fetal heart monitoring 1 hour after administration. Prior to discharge women in
the study will be asked to complete a questionnaire as to their preferences of route of
administration and side effects.
1. Recruitment, Consenting, and Confirming Eligibility: Women with obstetric, medical, or
psychosocial indications of induction of labor at UCLA Ronald Reagan Medical Center
will be evaluated for participation. Those who meet eligibility criteria will be
invited to participate. The subject will be counseled about the study, and if
interested, will undergo the consent process. Each potential subject will receive a
thorough overview of the study protocol and will review the consent form with study
staff. All questions will be answered. The subject will be advised that a decision not
to participate in the study will not affect the quality or availability of medical
services she will receive at the hospital. She will also be advised that she can stop
participating in the study at any time, for any reason, and that this will not impact
the services she receives. If the subject elects to participate, two copies of the
consent will be signed by the subject and research staff. A signed consent, along with
a copy of the Experimental Subjects Bill of Rights, will be given to the subject. The
other consent will be filed in a locked file cabinet.
A general medical and gynecological history and physical will be done as is standard of
care. Routine obstetric labs and any other medically indicated labs will be sent as is
standard of care. Patients will undergo a non-stress test and uterine contraction
monitoring prior to induction of labor. Obstetrical ultrasound will be reviewed or
performed if indicated per the physician. Assessment of the cervix and Bishop score,
pelvis, fetal size, and presentation will be performed. An unfavorable cervix is
defined as Bishop score of 6 or less (ACOG). Women with ruptured membranes will not be
able to participate. Gestational age will be determined on the basis of last menstrual
period, confirmed by earliest ultrasound, or a corrected estimated date of confinement
by the earliest ultrasound.
2. Misoprostol Administration/ Evaluation: The subject will be randomized to either of two
groups. Each participant will receive both a vaginal and buccal tablet, with one tablet
containing misoprostol. Subjects will be instructed by a nurse regarding buccal
placement and to swallow any residue remaining after 20 minutes.
Intravaginal administration of pill will be performed by a resident Physician or
midwife. The subject will remain recumbent for at least 30 minutes. The subject will
undergo fetal heart rate (FHR) and uterine contraction monitoring for at least 1 hour
after misoprostol administration. The subject may undergo further FHR and uterine
contraction monitoring per physician discretion. If the subject does not have adequate
uterine contractions (uterine contraction occurring at least every 5 minutes), the same
dosage and route of administration regimen will be repeated to 6 maximum dosage
(maximum of 150mcg). Cervical assessment of Bishop score will be performed with each
treatment during vaginal administration.
Treatment will continue until spontaneous rupture of membranes, active labor, or
favorable cervix (Bishop >6). Augmentation of labor using pitocin may start after 4
hours of last misoprostol dose according to routine protocol. Amniotomy may be
performed at the discretion of the managing obstetrician. If labor is not achieved
after receiving 150mcg of misoprostol, it will be categorized as a failed induction. At
this time, the subject may be offered oxytocin induction, foley bulb mechanical
dilation, or cesarean section, according to the fetal and participant condition.
Terbutaline 0.25mg subcutaneous may be given for tachysystole (5 uterine contractions
in 10 minutes) with FHR changes or FHR category II-III changes (minimal variability,
prolonged deceleration, repetitive variables, sinusoidal pattern, repetitive late
deceleration) that are not responsive to resuscitative measures ( oxygen
supplementation, side positioning, intravenous fluids) according to physician's
discretion.
3. Follow up: A short survey questionnaire assessing gastrointestinal side effects,
experiences, and preferences of route of administration will be given prior to
discharge.
Inclusion Criteria:
- Willingness to participate / consent in a placebo-controlled trial
- Age 18 and older
- Pregnancy between 34 and 42 years of gestation
- Admitted for labor induction because of either medical, obstetric, or psychosocial
indications
- Live singleton fetus
- Bishop score less than or equal to six
- Cephalic presentation
- Reactive non-stress test or Negative contraction test
Exclusion Criteria:
- Premature rupture of membranes
- Multiparity > 5
- Contraindication to vaginal or labor delivery
- Suspected placental abruption
- Significant hepatic, renal or cardiac disease
- Known hypersensitivity to misoprostol or prostaglandin analogue
- Recent prostaglandin administration for induction of labor
- Multifetal pregnancy
- Macrosomia > 4500g estimated fetal weight by ultrasound or leopold
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