Magnesium Sulfate Versus Placebo for Tocolysis in PPROM
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | April 2007 |
| End Date: | April 2009 |
| Contact: | Lorrie A Mason, MSN |
| Email: | lorrie@rocob.com |
| Phone: | 423 826-8086 |
Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes
Study compares the outcomes of women between 26 and 32 wks gestation with rupture of
membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo
of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.
membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo
of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.
The majority of studies of the effectiveness of tocolysis with PPROM were in the 1980s prior
to the commmon usage of antenatal steroids and prophylactic maternal antibiotics. In most
studies, tocolysis was not attempted prior to the onset of labor in this group of women. The
ACOG Practice Bulletin of June 1998 concedes that the recommendation of tocolysis to permit
administration of steroids and maternal antibiotics is based primarily upon consensus, not
consistent scientific evidence.
The purpose of this study, which will randomize 128 subjects to tocolysis or no tocolysis,
is to prospectively assess whether short term (48 hr) tocolysis affords benefit to women and
babies between 26 and 32 weeks gestation with PPROM.
Subjects will be enrolled at 1-2 high risk hospitals in Chattanooga and Knoxville. All
English and Spanish speaking women 18-45 years with PPROM and cervical dilation <4 will be
eligible. Women with suspected intrauterine infection, positive fetal lung maturity, or > 6
hours tocolysis at time of admission will be excluded.
Both groups of women will receive continuous fetal monitoring, antibiotics, and antenatal
steroids (if not previously administered). Both groups will be evaluated every 2-4 hours for
fetal and maternal well being. Both groups will receive IVF at 125cc/hr, and the treatment
group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2
grams/hr x 48 hrs.
to the commmon usage of antenatal steroids and prophylactic maternal antibiotics. In most
studies, tocolysis was not attempted prior to the onset of labor in this group of women. The
ACOG Practice Bulletin of June 1998 concedes that the recommendation of tocolysis to permit
administration of steroids and maternal antibiotics is based primarily upon consensus, not
consistent scientific evidence.
The purpose of this study, which will randomize 128 subjects to tocolysis or no tocolysis,
is to prospectively assess whether short term (48 hr) tocolysis affords benefit to women and
babies between 26 and 32 weeks gestation with PPROM.
Subjects will be enrolled at 1-2 high risk hospitals in Chattanooga and Knoxville. All
English and Spanish speaking women 18-45 years with PPROM and cervical dilation <4 will be
eligible. Women with suspected intrauterine infection, positive fetal lung maturity, or > 6
hours tocolysis at time of admission will be excluded.
Both groups of women will receive continuous fetal monitoring, antibiotics, and antenatal
steroids (if not previously administered). Both groups will be evaluated every 2-4 hours for
fetal and maternal well being. Both groups will receive IVF at 125cc/hr, and the treatment
group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2
grams/hr x 48 hrs.
Inclusion Criteria:
- English or Spanish speaking
- preterm premature rupture of membranes
- 26 - 32.6 weeks gestation
- cervical dilation
Exclusion Criteria:
- suspected intrauterine or intraamniotic infection
- > 6 hours of tocolysis prior to admission
- positive fetal lung maturity
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